Information Technology For Development Jobs in None, NC

Job Summary

The Director / Senior Director / Executive Director, CMC Regulatory Affairs is responsible for leading global regulatory CMC development, registration, and compliance activities from early development through commercialization. This role reports to the Head of Global Regulatory Affairs and may be based on-site or remote, depending on organizational needs. The position plays a critical role in defining and executing global CMC regulatory strategies in alignment with business and development objectives.

Key Responsibilities

Regulatory Strategy & Leadership

• Lead the development and execution of global CMC and device regulatory submission strategies in close collaboration with cross-functional project teams.
• Review CMC content and manage submission timelines to ensure alignment with business objectives.

Regulatory Compliance & Guidance

• Assess and communicate global CMC and device regulatory requirements to ensure development activities comply with applicable regulations and guidelines.
• Maintain current knowledge of evolving global CMC and device regulatory regulations, standards, and guidance, and communicate impact to stakeholders.

Quality by Design (QbD) & Risk Management

• Partner with CMC and technical teams to develop and document Quality by Design (QbD) strategies for novel manufacturing processes.
• Conduct risk assessments and develop mitigation strategies for global CMC and device regulatory matters.

Regulatory Submissions & Agency Interactions

• Lead preparation and review of CMC sections for regulatory submissions, including INDs, CTAs, IMPDs, NDAs, MAAs, supplements, annual reports, amendments, and regulatory correspondence.
• Prepare and coordinate responses to regulatory authority information requests during application review and post-approval maintenance.
• Serve as a primary regulatory interface with health authorities on CMC and device-related matters, including leading preparations for regulatory agency meetings.

Manufacturing & Inspection Readiness

• Collaborate closely with Manufacturing, Quality, and external partners to support GMP facility inspections and regulatory audits.
• Assess CMC-related and device changes and ensure timely and compliant reporting to global health authorities.

Cross-Functional Collaboration

• Work closely with Manufacturing, Quality, R&D, and external vendors to support development programs, commercialization activities, and lifecycle management.
• Communicate complex CMC strategies, novel manufacturing processes, and QbD activities clearly and effectively to internal stakeholders and regulatory agencies.

Education & Experience

• Bachelor’s degree in Chemistry, Biochemistry, Engineering, Life Sciences, or a related discipline required; advanced degree preferred.
• RAC or similar regulatory certification is a plus.
• Minimum experience requirements by level:
• Director: 10+ years of CMC regulatory or related pharmaceutical industry experience
• Senior Director: 12+ years
• Executive Director: 15+ years
• Demonstrated ability to define and execute global CMC regulatory strategies with minimal oversight.
• Strong understanding of drug development and lifecycle management, including interdependencies across functions.
• Small molecule experience preferred.
• Experience with pharmaceutical Quality by Design (QbD) concepts and implementation.
• In-depth knowledge of FDA and ICH regulations and guidelines, with experience serving as an FDA liaison; familiarity with EU and other global regulatory requirements preferred.
• Proven experience authoring and submitting INDs, CTAs, IMPDs, NDAs, MAAs, and supplements.
• Experience supporting post-market and commercialization CMC regulatory activities.

Company Description

Galvan Industries, established in 1958, specializes in providing unparalleled corrosion control solutions to steel fabricators and manufacturers. As the first hot-dip galvanizing operation in the Carolinas, the company has become the largest contract galvanizer in the Southeast. With decades of trusted expertise, Galvan Industries remains committed to quality, innovation, and exceptional service in its field.

Role Description

This company is seeking a Plant Operations Manager for their operations who will be trained in all aspects of production and gradually take on broader operational and business responsibilities. The ideal candidate is someone who wants to fully understand how the operation runs from the process on the floor to the business and operational decisions made at the leadership level.

Responsibilities

• Learn and oversee daily production activities of the operation, ensuring safety, quality, and production goals are met.
• Develop a strong understanding of the full hot-dip process and how each step impacts quality, efficiency, and cost.
• Support scheduling, workflow coordination, and manpower planning to keep production moving efficiently.
• Work directly with current Plant Manager on operational planning, problem solving, and performance improvement initiatives.
• Identify production issues and inefficiencies, investigate root causes, and help implement practical solutions.
• Help manage and develop production employees, reinforcing safety standards and accountability.
• Track and review production metrics and participate in discussions around productivity, downtime, quality, and continuous improvement.
• Gradually take on more responsibility related to operations, budgeting, capital planning, and cross-department coordination.
• Participate in business and leadership meetings alongside senior management and executive leadership.

Qualifications

• Bachelor’s degree required (engineering, manufacturing, operations, or business-related field preferred). Advanced education is a plus.
• Manufacturing or industrial experience strongly preferred; metal processing experience is a plus but not required.
• Demonstrated ability to learn complex processes and apply that knowledge in a leadership role.
• Experience leading teams, projects, or operations in a manufacturing environment is preferred.

Skills & Attributes

• Strong critical-thinking and problem-solving skills.
• Ability to understand both the technical and business sides of a manufacturing operation.
• Comfortable communicating with all levels of an organization, including executives.
• Organized, detail-oriented, and able to manage multiple priorities.
• Hands-on mindset with the ability to step onto the production floor when needed.
• Professional presence and confidence in meetings and discussions.

• Earn $100,000 - $110,000 annually
• Annual wage increases until maxed
• $5,000 sign-on bonus in 10 monthly payments for experienced drivers
• Paid training
• Late-model trucks
• Unlimited driver referral program ($2,000 - $3,000 per referral, paid out over 180 days)
• Paid time off after 1 year, plus 6 paid holidays after 90 days
• Medical, dental, vision, life insurance, & 401(k)
• Paid online orientation

• Dedicated account
• OTR - car haul
• Steady freight

See where the road can take you when you drive for Hogan!

Hogan is family-owned and operated with over 100 years of experience in the Transportation Industry. We continue a tradition of unparalleled, personalized service to clients and drivers. Hogan utilizes first-class equipment and advanced technology to help our drivers be successful. Drivers can expect a career embodied by safety, teamwork, professionalism, integrity, and the constant pursuit of excellence.

Our nationwide network of dedicated opportunities allows drivers the opportunity to find predictable home time, competitive pay rates, and stable customer freight that best suits their needs. Our goal is to attract, recruit, and retain excellent employees that are passionately motivated to represent Hogans core values. If this sounds like you, apply today to join the Hogan team!

• Valid Class A CDL
• 1 year of Car Hauling experience preferred OR Minimum 2 years of recent tractor-trailer experience that includes 1 year of specialized trailer experience to qualify for our Car Haul training program!

(*Speak to a recruiter today for more details!)

Flatbed CDL A-Truck Drivers Earn $89,700-$104,000 Annually!

Pay & Benefits:

• 
  
• Earn $1,725-$2,000 Weekly
  
• $0.69 CPM
  
• Rider & Pet Policies*
  
• Unlimited Driver Referral Program ($2,000-$3,000 per referral, paid out over 180 days)
  
• Paid time off after 1 year, plus 6 paid holidays after 90 days
  
• Medical, Dental, Vision, Life Insurance, 401(k)
  
• Late-Model Trucks
  
• Paid Online Orientation
  

Job Details:

• 
  
• NO DRIVER UNLOAD NO TOUCH Freight
  
• Simple Strapping/securing PODS to the trailer - NO Tarping or Chaining!
  
• Average 2,500 Miles Per Week
  
• Dedicated Flatbed Account - OTR
  

Requirements:

• 
  
• Valid Class A CDL
  
• Minimum 9 months of recent tractor-trailer experience
  
• Must be willing to assist with other No touch dedicated accounts
  

See where the road can take you when you drive for Hogan!

Hogan is family owned and operated with over 100 years of experience in the Transportation Industry. We continue a tradition of unparalleled, personalized service to clients and drivers. Hogan utilizes first-class equipment and advanced technology to help our drivers be successful. Drivers can expect a career embodied by safety, teamwork, professionalism, integrity, and the constant pursuit of excellence. Our nationwide network of dedicated opportunities allows drivers the opportunity to find predictable home time, competitive pay rates, and stable customer freight that best suits their needs. Our goal is to attract, recruit, and retain excellent employees that are passionately motivated to represent Hogans core values. If this sounds like you, apply today to join the Hogan team!

*Speak to a recruiter today for more details!

Marsh McLennan Agency provides business insurance, employee health & benefits, retirement, and private client insurance solutions to organizations and individuals seeking limitless possibilities. With offices across North America, we combine the personalized service model of a local consultant with the global resources of the world's leading professional services firm, Marsh McLennan. A day in the life. As our Client Manager on the Business Insurance Select team, you will manage relationships with clients to provide best in class service and drive growth. You'll serve as the client contact to answer questions, resolve billing issues, make policy changes while delivering prompt, courteous, knowledgeable assistance with your day-to-day communications, including renewals, certificates, endorsements, etc.

Our future colleague. We'd love to meet you if your professional track record includes these skills: A high school diploma is required. Minimum of three (3) years Business Insurance experience. Insurance designations (i.e. INS, AAI, CISR) and/or demonstrated knowledge of Business Insurance coverages. Legal work authorization to work in the U.S. on a permanent and ongoing basis without the need for sponsorship now or in the future. These additional qualifications are a plus, but not required to apply: Associates or Bachelors degree preferred. Property & Casualty license (or ability to obtain within 90 days). Experience working with EPIC, Sagitta, and ImageRight. We know there are excellent candidates who might not check all of these boxes. Don't be shy. If you're close, we'd be very interested in meeting you.

Valuable benefits. We value and respect the impact our colleagues make every day both inside and outside of work. Our culture promotes colleague well-being through robust benefits programs and resources, professional and personal development opportunities, and fulfillment through meaningful work. Some benefits included in this role are: Generous time off, including personal and volunteering. Tuition reimbursement and professional development opportunities. Flexible hybrid work. Charitable contribution match programs. Stock purchase opportunities.

As a SONIC Drive-In Assistant Manager, you are responsible for assisting the General Manager in managing the daily operations of the restaurant to provide quality food in a clean, safe, and efficient manner so that guests will have an enjoyable experience at the SONIC Drive-In. Responsibilities include:

• Hiring, training, supervising, managing, directing, and developing great people ready to serve a SuperSONIC experience to every guest
• Making every guest a repeat customer by ensuring the guest leaves the lot satisfied every time
• Helping employees understand the big picture and their role by sharing the \"why\" behind tasks
• Celebrating team successes and coaching for better performance
• Setting clear expectations and providing continuous feedback throughout shift
• Creating an upbeat positive atmosphere during the shift that makes work fun
• Managing the majors: food and paper, labor, and guest service
• Maintaining and enforcing SONIC safety and sanitation standards
• Relentlessly complying with all federal, state, and local laws and regulations

What you'll need:

• Excellent leadership and communication skills
• High standards for self and the team
• Positive attitude, especially during rushes or stressful situations
• Resiliency trying different approaches to solve a problem; working to get better every day
• Eagerness to learn and grow professionally and personally
• Ability to prioritize and complete tasks accordingly
• Effective communication skills; basic math and reading skills
• Willingness to work irregular hours, including nights, weekends, and/or holidays

The fine print:

As required by applicable law, SONIC Drive-In franchise organizations will make reasonable accommodations to enable individuals with disabilities to perform the essential functions of the job.

Each franchise organization is an independent employer and thus responsible for making its own employment-related decisions. Nothing in these materials should be construed as the franchisor being involved in or having control over a franchise employee's essential terms and conditions of employment.

Requirements:

• Ability to work irregular hours, nights, weekends and holidays
• General knowledge and understanding of the restaurant industry or retail operations required
• Minimum of six months of restaurant management experience (QSR) or one year entry level retail management experience required. Experience running shifts without supervision
• Effective communication skills; basic math, reading and computer skills
• Ability to follow directions and work with autonomy once given directions; ability to multi-task and successfully solve problems
• Willingness to abide by the appearance, uniform and hygiene standards at SONIC

Additional info:

• Friendly and smiling faces that enjoy providing courteous food service to our guests!
• Professional individuals who value people and demonstrate respect for others!
• A team player willing to meet and exceed drive-in goals and objectives.
• Strong leadership skills with the ability to motivate and lead team members.
• Dedicated individuals with a proven track record of building sales, creative marketing, expense management and developing people into successful teams.

The SONIC Drive-In restaurant experience will always be groovy, right on, awesome, wicked, fab, the bee's knees, cruisin' ... you get the picture! It's downright sensational!!

All that's missing is you, so apply today!

SONIC and its independent franchise owners are equal opportunity employers.

You are applying for work for a franchisee D.L. Roger Corp of Sonic, not Sonic Corporate, or any of its affiliates. If hired, the franchisee will be your only employer. Franchisees are independent business owners who set their own wage and benefit programs that can vary among franchisees.

Abercrombie & Fitch Co. is a global, digitally led omnichannel specialty retailer of apparel and accessories catering to kids through millennials with assortments curated for their specific lifestyle needs. The company operates a family of brands, including Abercrombie & Fitch, YPB, abercrombie kids, Hollister and Gilly Hicks, each sharing a commitment to offer products of enduring quality and exceptional comfort that support global customers on their journey to being and becoming who they are. Abercrombie & Fitch Co. operates over 750 stores under these brands across North America, Europe, Asia and the Middle East, as well as the e-commerce sites , , and . At Abercrombie & Fitch Co., we lead with purpose and always put our people first.

The Assistant Manager is a multi-faceted role that merges business strategy, operations, creativity, and people management. Strategically, assistant managers are responsible for driving sales results by analyzing the business and providing best-in-class customer service. They are responsible for overseeing daily store operations including opening and closing routines and driving efficiency in all store processes. Assistant managers leverage their creative expertise through floorset updates, styling recommendations and product knowledge. Assistant managers are also talent leaders, driving everything from recruiting and training to engagement and development. They are expected to show up, bringing their best selves every day. With a promote from within philosophy, our Assistant managers will build upon their initial foundation and have the opportunity to grow into the future leaders of our store's organization.

What You'll Do

• Customer Experience Drives Sales
• OMNI Channel Fulfillment
• Store Presentation and Sales Floor Supervision
• Store & Stockroom Operations
• Staffing, Scheduling, and Payroll Management
• Training and Development
• Communication
• Asset Protection

What it Takes

• Bachelor's degree OR one year of supervisory experience in a customer-facing role
• Strong problem-solving skills
• Ability to show up in a fast-paced and challenging environment
• Team building skills
• Self-starter
• Strong interpersonal and communication skills
• Drive to achieve results
• Adaptability / Flexibility
• Multi-Tasking
• Fashion Interest & Knowledge

As an Abercrombie & Fitch Co. (A&F Co.) associate, you'll be eligible to participate in a variety of benefit programs designed to fit you and your lifestyle. A&F is committed to providing simple, competitive, and comprehensive benefits that align with our Company's culture and values, but most importantly with you! We also provide competitive incentives to reward the commitment our associates have for moving our global business forward: Quarterly Incentive Bonus Program Paid Time Off Paid Volunteer Day per Year, allowing you to give back to your community Merchandise Discount Medical, Dental and Vision Insurance Available Life and Disability Insurance Associate Assistance Program Paid Parental and Adoption Leave 401(K) Savings Plan with Company Match Training and Development Opportunities for Career Advancement, we believe in promoting from within A Global Team of People Who'll Celebrate you for Being YOU

Looking for a career or just part time work? Either way, we would love to have you join our team! Pool Scouts is a professional work environment where you build customer relationships while providing superior cleaning and maintenance services to residential pools.

The Position:

• Seasonal, Part Time or Full Time
• Maintaining and cleaning residential pools
• Driving a company-issued van
• Minor repairs
• Use of technology (phone, tablet) to record and track daily activities
• Focus on excellent Customer Experience
• Committed to the Pool Scouts way
• Clean driving record

About Us:

Pool Scouts is a customer service centric company dedicated to the residential pool market. We are outfitted with the latest equipment and backed by the dedication and knowledge of a top-notch staff. Our goal is to deliver quality services in an organized and efficient way, so setting our technicians up for success is our highest priority.

Competencies of a Professional Technician:

• Positive Attitude
• Good Communicator
• Likes Working with Others
• Problem Solver
• Great Work Ethic
• Enjoys working outdoors
• Supports the team and has fun!

Requirements:

• Certified Pool Technician (CPT) or Certified Pool Operator (CPO) certification, or willingness to be certified
• Nationwide background check.
• Must have a valid driver's license and pass insurance coverage check
• Ability to work for long periods of time in extreme outdoor temperatures
• Able to lift a minimum of 50 pounds
• Proficiency with use of tablet or smart phone.

Why Pool Scouts?

• We provide a safe & happy work environment!
• We provide quality paid training!
• We take care of our people!
• We are committed to great customer care!

Compensation: $16.00 - $24.00 per hour

Pool Scouts is a professional take on the pool service industry, setting the new standard for excellent customer service. Our pool technicians, or 'Scouts' as we like to call them, are a group of motivated, dynamic individuals who believe that quality service is built on reliability and customer confidence. We go the extra distance to ensure that we provide professional pool technicians our clients can trust. Our ideal Scout has a fun and positive attitude with a willingness to learn - no previous pool experience required. Not to mention, you basically get paid to work out as you'll be spending so much time outside!

Do you want to serve your local community and have a great time doing it? If so, Pool Scouts could be your perfect opportunity.

Uncap Your Potential at America's Largest Coca-Cola Bottler Pour Your Passion into Purpose!

We're more than beverageswe're building meaningful careers and vibrant communities. Join our team where your talent meets purpose, and every teammate directly shapes our success.

Join us - your refreshing new chapter starts here!

The Delivery Merchandiser Trainee is a fast-paced position responsible for learning and becoming efficient in the daily duties of route delivery and merchandising in all disciplines, including stocking and facing products on shelves and displays, in coolers and cooling vaults. This individual should be capable of giving route relief when and where needed, as well as being prepared to take a permanent route assignment in any route delivery discipline.

• Learn to drive a Class A CDL vehicle and obtain required licensing within 10 weeks of training start date. Under supervision learn processes, and gain the skills necessary to service customers using all equipment utilized in the delivery process such as invoicing using a handheld device; begin and end of shift check-in, out accounting procedures for cash and paperwork accountability. Properly secure company assets and inventory, and while safely and properly handling products upon delivery at customer locations
• Learn and develop merchandising habits and techniques to ensure customer and consumer satisfaction while ensuring Company merchandising standards are met and understand how to execute commercial plans in our customer's outlets
• Develop good rotation practices and the importance of point of sales such as racks and shippers; learn how to effectively build and maintain displays of our products, product facing, and brand order along with proper backroom management of our products
• Develop customer service skills by working with our customers to understand their needs and communicating back to the appropriate manager any customer service issues
• Responsible for appropriate behavior while executing job functions, promoting personal safety, and the safe use of needed equipment. Learn and adhere to company standards on safety, equipment safety, and proper usage and learns all Federal Motor Carrier Safety Administration rules regarding DOT and Hours of Service

• Beverage, delivery industry knowledge
• Customer management
• Continuous improvement and initiative
• Sales ability
• Safety-focused
• Previous route delivery, direct store delivery, stocking, merchandising products, or retail management experience is strongly preferred
• Strong customer service skills
• Must be self-motivated with a high degree of integrity and be able to perform job duties with minimal supervision on a timely basis
• Must reflect dependability, initiative, professional demeanor, and the ability to exercise sound judgment
• Ability to work in a fast-paced, continuous lifting environment
• Ability to lift, up to, 75 pounds, repeatedly and multiple times a day
• Availability and willingness to work some weekends holidays

• Valid driver's license for your state of residency and excellent driving history reflected in the seven-year Motor Vehicle Report will be reviewed
• The ability to obtain a Commercial Driver's License (Class A CDL), not required for hire
• Ability to pass and maintain D.O.T. physical requirements

Work environment will vary, including but not limited to exposure to weather conditions, coolers, and customer storage areas which may be non-temperature controlled

Equal Opportunity Employer - All qualified applicants will be considered for employment without regard to disability, protected veteran status, or any other characteristic protected by applicable law.

Nearest Major Market: Wilmington

The Nothing Bundt Cakes (NbC) Guest Service Representative creates a warm, welcoming environment for our guests, offers creative solutions for unique celebratory occasions and sells our delicious cakes. The Guest Service Representative is the first point of brand contact in our bakery and serves in an essential role to engage and bring joy to our guests, create a memorable experience and leave a positive, lasting impression. The Guest Service Representative embodies NbC core values and demonstrates a strong commitment to guest satisfaction as well as excellence and efficiency in the workplace.

Accountabilities/Duties:

* Promptly greets walk-in and phone guests with genuine warmth and helpful enthusiasm to determine interests and needs, and follows NbC Sweet Steps of Service to create a superior guest experience.

* Maintains strong product knowledge to educate guests on NbC cake distinction, size and flavor profile options, pricing, special promotions, and complimentary retail merchandise.

* Suggests additional merchandise, including balloons, candles, and cards, to complete a unique celebration.

* Processes guest orders efficiently and accurately utilizing the point-of-sale system and invite guests to join NbC Email Club to benefit from special promotions and remain connected.

* Upholds a clean and organized bakery presentation, which may include routine sweeping/mopping of the floor, and dusting/cleaning of countertops, windows, and other surfaces.

* Replenishes retail merchandise and cake display case to ensure a strong visual presentation.

* Assists the Crafter in preparing cake decorations and packaging supplies as needed.

* Complies with all health and safety guidelines and NbC policies and procedures, including strict adherence to dress code and personal hygiene.

* Maintains a consistent work attendance and punctuality record.

Core Values and Competencies:

* Servant's Heart

* Goes above and beyond to support the team or guest, and is reliable, trustworthy and responsive.

* Keeps the good of the team or guest ahead of personal interests or gain.

* Displays humility and empathy in interactions with others.

* Spirit of a Champion

* Demonstrates pride in responsibilities, an intense drive and a passion to succeed.

* Takes initiative and 100% ownership of responsibilities, with zero excuses for issues within direct control.

* Operates with a strong sense of urgency and adheres to NbC brand standards.

* Genuine Connections

* Projects warmth, enthusiasm, and optimism that attracts others.

* Builds positive, productive relationships with all team members.

* Listens actively and communicates openly, clearly and respectfully.

Knowledge, Skills, and Abilities:

* Exhibits high energy and strong interpersonal skills; is friendly, helpful, positive, patient, socially confident and communicative.

* Enjoys interacting with diverse people and excels at providing a superior guest experience.

* Can perform multiple tasks simultaneously while maintaining meticulous attention to detail.

* Is diligent, organized and self-motivated.

* Has the ability to understand and carry out oral and written instructions and request clarification when needed.

* Is comfortable with new technology and has the ability to operate a point-of-sale system.

* Understands basic arithmetic; can perform calculations when needed and provide monetary change using U.S. currency.

* Has the capacity to stand for extended periods of time and work in a fast-paced environment.

Education, Certifications and Work Experience Requirements:

* Applicants must be 16 years of age or older.

* While no formal education or work experience is required, previous guest service experience at a bakery, restaurant or retail store is a plus.

Work Availability:

Must have the flexibility to work various shifts, including early mornings, evenings, weekends and holidays, based on changing business demands.

Compensation: $9.00 - $13.00 per hour

Join Our Growing Family

From \"Happy Birthday\" to \"Just Because,\" Nothing Bundt Cakes is committed to bringing joy to our guests and our communities and helping make every celebration sweeter! Each bakery offers a warm and welcoming work environment with team members who embody this joy-filled brand and possess a Servant's Heart, the Spirit of a Champion and the ability to make Genuine Connections.

With over 500 bakery locations in 40+ U.S states and in Canada, there's plenty of opportunity to join our family!

Click here to learn more about Nothing Bundt Cakes.

Employees at a franchised Nothing Bundt Cakes bakery location are employed by the franchise owner/operator and are not employees of Nothing Bundt Cakes Corporate (the franchisor). All inquiries about employment should be directed to the franchise owner/operator and not to Nothing Bundt Cakes Corporate. Each franchise owner/operator is responsible for ensuring compliance with local, state and federal law.

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