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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.

Regional Director of Operations, West Coast

(Must reside within a commutable distance to SFO)

Compensation Target $200,000 to $225,000 Salary commensurate with experience Plus significant Bonus Incentives. Happy to discuss your income target!

Our client has been in business for over 10 years but is still very much in an entrepreneurial and growth mindset. They have over 1200 employees, but still operate in a very “lean” fashion. In these + 10 years they have gone from $0 to north of $100M and are not slowing down.The right person for this position will bring a very “Can do” attitude and leadership skills that lead by example and are driven by success.

Our client is one of the top providers of transportation to the airline industry across the country. Reporting directly to the CEO, the Regional Director of Operations will be responsible for the successful day-to-day operations of the stations in his/her designated region. The Regional Director of Operations will provide leadership and direction to their station management teams and will be responsible for reinforcing a performance culture in a way that is inspiring and holds true to our core values (Teamwork, Integrity, EX=CX, Growth and Safety).

With direct oversight of the designated station leaders, the Regional Director of Operations will align teams through specified performance measures that achieve our service, safety, and financial goals. Further, the Regional Director of Operations will ultimately be responsible for managing delivery of the Company vision.

Job Responsibilities:

• Ensures each station in region portfolio achieves Company financial goals. Regularly analyzes financial performance to ensure each station is on track to meet performance metrics.
• Conducts monthly business reviews with each station leader across Company key performance indicators and adjusts plans with station leadership, as needed, to achieve results.
• Develops quarterly business plans with each station leader to ensure each station is prepared and staffed for planned local events, as well as trained to execute during unplanned events that impact station operations.
• Ensures all Station Leaders are executing effective scheduling practices: schedules posted on time, all trips covered according to contractual guidelines, proper LOD coverage, etc.
• Partners with HR to manage station recruiting, ensuring each station is fully staffed with proper availability and that station leaders complete onboarding process correctly and in a timely manner.
• Develops succession plans for staffing needs and demonstrates a strong ability to recruit and develop others. Assesses talent at all levels and builds a bench of talent.
• Identifies and develops designated trainers for station leaders and drivers within the region. Ensures that all new hires are effectively trained by certified trainer.
• Effectively addresses performance issues and holds teams accountable in a constructive and timely manner. Appropriately partners with HR and elevates concerns with a sense of urgency.
• Acts as point of escalation when service issues arise, advises station leaders on proper reporting and documentation. Ensures all complaints are answered with 24 hours.
• Leverages data from observations and reported service issues to identify root cause and implement processes to improve execution in a measured way.
• Engages station leaders to identify operational improvements in areas such as route optimization, fleet utilization, fuel expenditures, and routine maintenance costs.
• Builds a best-in-class safety culture in region by leveraging training tools, employee engagement, recognition, and coaching. Ensures all safety policies are implemented and followed.
• Ensures auditing of fuel cards, time and attendance, vehicle maintenance, office paperwork and record keeping, vehicle documents, etc. to maintain compliance with Company policy and mitigate risk and exposure.
• Leads the fleet managers to ensure vehicle maintenance schedules are in place, correct number or vehicles are at each station, correct maintenance tools are present in stations/vans, and vehicles are maintained under the hood and inside the van as required.

Qualifications & Requirements

As a leader within the organization, the Regional Director of Operations must be passionate about customer service, have experience in the transportation, airline, hospitality, or retail industry. Other requirements include:

• 5-7 years of multi-unit leadership experience.
• Flexible schedule to include nights and weekends as required to meet the needs of our 24/7/365 operation.
• Excellent written and verbal communication skills, including the ability to effectively communicate with all levels of the organization.
• Strategic thinking and organizational skills that enable the ability to lead direct reports shoulder to shoulder, manage multiple priorities, and meet deadlines in a fast-paced and dynamic environment.
• Strong leadership skills and the ability to work with employees from a variety of backgrounds, embrace diversity, promote inclusion, and motivate and develop a high performing team.
• Extensive experience in P&L analysis and demonstrated problem-solving skills.
• Proficient in Microsoft Office.
• Travel Requirements – 50 – 75% travel required within assigned region and to headquarters, as needed.

Compensation:

• Significant Salary commensurate with experience ($200 to $225K is the target, let’s discuss your qualifications and income expectations).
• Significant and achievable bonus program at 25% of salary.
• Full benefit package.

This is a great opportunity for a person driven to succeed and looking for a career growth opportunity. If this sounds like a good fit for you, I can tell you all about the company and opportunity, let’s have a confidential conversation. You can reach me at 3 cell) and . Thanks! Mark Crabtree

Get ready to embark on an exciting journey of growth and excellence as an Assistant Director at Celebree School! In this role, you'll work alongside the School Director to champion our mission, vision, and values while ensuring a focus on talent, brand, and operations. Through building a school family, nurturing talent, and fostering positive community relationships, you'll be at the helm of creating an environment where both children and team members can have fun and grow! Make a difference and have fun while working alongside our dedicated team to grow people both BIG and small.

At Celebree School we grow people BIG and small. This promise reflects our holistic approach to growth, emphasizing the importance of nurturing both children and team members to reach their fullest potential. Celebree provides a supportive environment where team members have access to continuous learning, development opportunities, individual growth plans, and career pathways. Join us at Celebree and be part of a company that not only cares about the growth of children but also prioritizes the growth and development of its team members. Let's grow BIG together!

Free Uniform Items

Team Building Initiative

Employee Referral Bonuses

Child Care Discounts

Free Continuing Education Units

Career Development

Benefits may vary by location:

Paid time off

Monday through Friday: 6:30 am to 3:00 pm or 10:00 am to 6:30 pm (Alternating shifts)

As an Assistant Director, you will be given the tools, resources, and training to assist the School Director with the following responsibilities:

• Identify and attract the best talent to join the team.
• Support team growth and development through comprehensive training and guidance.
• Build a school community that attracts new families and team members fostering positive relationships
• Ensure compliance with all federal and state laws, regulations, and Celebree standards, policies, and procedures.
• Management of childcare operations, from scheduling to financial management and documentation, ensuring smooth operations and record-keeping
• Ensure exceptional customer service experiences, e.g., thorough, friendly tours (visits); welcoming environment; accessible for parent meetings, phone calls, etc.;
• Support and lead new company initiatives

• Minimum of an Associate's Degree
• Director Qualified strongly preferred
• Preschool Lead Teacher, Infant Toddler, and School Age certification strongly preferred.
• Business and/or accounting experience as well as experience managing in childcare desired.

At Celebree School we grow people BIG and small. This promise reflects our holistic approach to growth, emphasizing the importance of nurturing both children and team members to reach their fullest potential. Celebree provides a supportive and nurturing environment where team members have access to continuous learning, development opportunities, individual growth plans, and career pathways. At Celebree, you'll be part of a collaborative and inclusive team culture where your ideas are valued, and your contributions are recognized. We foster an environment of open communication, respect, and teamwork, where every voice matters.

• Most Competitive Salaries in Houston
• Annual Bonus Incentives
• Comprehensive Medical, Dental & Vision
• Generous PTO
• 10 Paid Holidays
• 403(b) Retirement Plan with 5% Company Match
• Short-term & Long-term Disability
• Flexible Spending Accounts
• Commuter Benefits
• Wellness Programs
• Educational Assistance (Student Loan / Tuition Assistance)

When you join Sunrise Senior Living, you will be able to use your unique skills to empower residents to live longer, healthier, and happier lives. Not only will you build meaningful relationships with residents, their families, and team members alike, you will also gain joy in serving others and deep fulfillment in your work. Explore how you can follow your passions and shed light on meaningful ways to serve, grow, and shine together.

Sunrise Senior Living was again certified as a Great Place to Work by Activated Insights. This is the 7th time Sunrise has received this top culture and workplace designation, highlighting the special place Sunrise is to be a part of.

Job ID: 2

*Relocation Assistance to Charlottesville, VA*

The Resident Care Director (RCD) serves as the nursing clinical leader for the community and is responsible to lead and manage the health and wellness along with coordination of care and services to residents within the community. Responsible for oversight and implementation of all Care programs, regulatory compliance, recruiting, and performance management.

Responsibilities:

As a part of the Sunrise team, supporting our Mission, Principles of Service and Core Values is a fundamental part of this job. Our foundational belief is the sacred value of human life. The unique responsibilities for this role include but are not limited to the essential functions listed as follows:

Managing Health and Wellness:

• Provides strategic leadership for resident care in the community by managing, directing, and monitoring the nursing team as applicable by State/Provincial law, to promote the health and wellness of the resident population.
• Provides clinical care through the direct application of the nursing process; performs and documents resident assessments and progress notes, evaluates changes in care needs, completes Individualized Service Plans (ISP)/Individualized Care Plan (ICP), provides or delegates hands-on clinical care as indicated by the plan of care, and evaluates resident outcomes.
• Collaborates with physicians, pharmacists, and other clinical providers to coordinate care and services for the residents.
• Serves as the CLIA Director as applicable for the community and according to the federal and state/provincial requirements.
• Partners with Neighborhood Coordinators to promote an integrated and collaborative approach to wellness operations and resident care.
• Collaborates with Sales partners to determine community capability and assess potential residents' appropriateness for move-in.
• Seeks direction from a Registered Nurse as needed in accordance with state/provincial regulations and nurse practice acts.

Medication Management:

• Provides strategic leadership for resident care in the community by managing, directing, and monitoring the medication care managers, as applicable by State/Provincial law, to promote the health and wellness of the resident population.
• Provides oversight of the community medication management program to promote resident safety in the medication use process including onboarding, training, and performance reviews.
• Provides clinical training and education, as needed, to nurses, medication care managers, care managers, and others who provide resident care. Performs skill evaluation to assure clinical capability of care team members.

Quality Assurance and Regulatory Compliance:

• Tracks, trends, and reports clinical quality data to identify risk.
• Participates actively as a member of the community Quality Assurance and Performance Improvement committee.
• Leads clinical quality and process improvement initiatives within the community to mitigate risk and improve resident care outcomes.
• Recruits, hires, and trains clinical team members and is responsible for performance management, evaluations, and engagement.
• Completes direct report team member staffing and scheduling according to operational and budgetary guidelines.
• Partners with the community leadership team to promote resident safety and compliance with Risk Management and OSHA/British Columbia Workers Compensation Act and Occupational Health and Safety Regulation requirements.
• Serves as the ICC and CLIA Director as applicable for the community.
• Responsible for infection control programming, including delegation of infection control preventionist, as per state/provincial requirements.
• Assures compliance with all Federal, State/Provincial, board of nursing, and other applicable regulations.

Financial Management:

• Manages the department budget to include labor/labour and other expenses and understands it's impact on the community's bottom line.
• Processes and submits monthly expenses and budget data in a timely manner, per Sunrise policies and internal business controls.
• Understands the internal costs associated with all Sunrise resident care programs.

Training, Leadership and Team Member Development:

• Partners with the Regional Director of Resident Care and/or Executive Director in the delivery and participation in Sunrise University training and self-study programs.
• On-boards new RCD leaders and other department coordinators as needed.
• Develops a working knowledge of state/provincial regulations and ensures compliance through supervising and coaching team members.
• Completes clinical team member staffing and scheduling according to operational and budgetary guidelines when assigned to a community.
• Holds clinical team accountable, corrects actions when necessary, and documents.
• Attends regular meetings; Stand Up, Cross Over, Department Head, Town Hall, QAPI, and others as directed by the Executive Director.
• Keeps abreast of professional developments in the field by reading and attending conferences and training sessions.
• Maintains compliance in assigned required training and all training required by state/province or other regulating authorities as applicable to this role to ensure that Sunrise standards are always met.

Qualifications:

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed throughout this job description are representative of the knowledge, skills, and abilities required.

• Graduate of an accredited college or school of nursing with a current state/provincial license as a professional Registered Nurse (RN).
• Minimum two (2) years RN experience with at least one (1) year experience in home health, assisted living, or long-term care environment preferred.
• Minimum of one (1) year nursing management experience, including hiring, coaching, performance management, scheduling, and daily operations supervision.
• Certified in CPR and First Aid.
• Demonstrated knowledge of applied nursing practices, techniques, and methods in accordance with federal, state/provincial and board of nursing requirements.
• Knowledge of infection control practices and prevention of disease transmission.
• Ability to delegate assignments to the appropriate individuals based on their demonstrated skill capability and in compliance with all regulations.
• Experience in tracking, trending, and analysis of clinical performance data preferred.
• Experience in quality and clinical process improvement and risk assessment preferred.
• Experience in staff development, training, and/or clinical education preferred.
• Proven ability to handle multiple priorities, organize efficiently, and manage time effectively.
• Demonstrated critical thinking, clinical judgment, and decision-making skills.
• Computer proficiency with electronic medical records, the Microsoft Office suite, and the ability to learn new applications.
• Ability to work weekends, evenings and flexible hours as needed for resident care/services, including 24/7 on call responsibility.

Ready to take the next step and make a bigger impact than you ever imagined? As part of our team, you will help brighten the future for everyone at Sunrise and beyond. That is why we make it a priority to celebrate the unique ways you bring moments of togetherness and joy to everyone you serve. And when combined with the support, benefits, and growth opportunities we offer, the result is a career that Positively shines with everything you need to reach your goals at work and in your life.

We also offer benefits and other compensation that include:

• Medical, Dental, Vision, Life, and Disability Plans
• Retirement Savings Plans
• Employee Assistant Program / Discount Program
• Paid time off (PTO), sick time, and holiday pay
• Daily Pay offered to get paid within hours of a shift (offered in the U.S. only)
• Tuition Reimbursement

SUMMARY: The Director of Lateral Partner Recruitment and Integration plays a pivotal role in advancing Goulston & Storrs' strategic growth by identifying, attracting, and successfully integrating high-performing lateral partners and groups who align with the firm's values, client service standards, and long-term business goals. This individual partners closely with the firm's leadership, practice group chairs, and business professionals to drive a best-in-class recruitment and integration experience that strengthens the firm's culture of collaboration, innovation, and inclusion.

This role requires a deep understanding of the legal markets in Boston, New York and Washington, D.C., and a demonstrated ability to execute senior-level lateral hiring in a manner that reinforces the firm's commitment to practical solutions, inclusive culture and strong relationship building. Working as a peer to the Director of Associate Recruitment and Integration, the Director of Lateral Partner Legal Recruitment and Integration will work collaboratively across the Legal Talent, Business Development, and Practice Group teams to ensure a well-coordinated, professional and seamless candidate experience, reflecting the firm's emphasis on teamwork, thoughtful decision making and the development of long-term, successful professional relationships.

Key Responsibilities

Strategic Recruitment

• Execute on a proactive strategy for lateral partner and group recruitment that supports the firm's growth priorities and practice strengths, including real estate, corporate, litigation, private client and trust, and other core areas.
• Build and maintain strong relationships with legal search professionals, prospective partners, and other market influencers to enhance the firm's visibility and reputation as an employer of choice.
• Partner with firm leadership to assess and report on market trends, identify talent gaps, and assess strategic opportunities for expansion.
• Manage the full lifecycle of lateral hiring, including candidate sourcing, evaluation, due diligence, offer development and socialization, and onboarding and integration coordination.

Evaluation & Due Diligence

• Conduct rigorous candidate assessments, analyzing business plans, financial data, client relationships, and cultural fit in collaboration with firm management.
• Oversee the due diligence process, ensuring confidentiality and accuracy in all communications and documentation.
• Prepare and present comprehensive candidate profiles and recommendations to the Managing Directors, Executive Committee, practice group co-chairs and other stakeholders.

Integration & Retention

• Lead the firm's lateral partner integration program, ensuring new partners are welcomed, supported, and positioned for long-term success.
• Collaborate across departments — including Business Development, Client Value, Finance, Marketing, IT, and HR — to coordinate seamless onboarding and client transition support.
• Design individualized integration plans, track key milestones, and measure outcomes related to client engagement, collaboration, and financial performance.
• Continuously evaluate and refine integration processes to promote engagement, retention, and productivity.

Data & Reporting

• Maintain accurate recruitment and integration metrics, reports, and analytics to inform decision-making and track progress toward firm goals.
• Monitor legal industry hiring trends, compensation data, and competitor activity to keep the firm's strategies aligned with market conditions.
• Provide leadership with actionable insights and recommendations for continuous improvement.

Operations

• Negotiate search firm agreements and manage search firm relationships in collaboration with Director of Associate Recruitment and Integration.
• Collaborate with Director of Associate Recruitment and Integration to develop and manage Legal Recruitment budget.
• Contribute to a team culture that focuses on positive collaboration, continuous improvement and innovation.

Qualifications

• Bachelor's degree required; JD or advanced degree strongly preferred.
• Minimum of eight (8) years of experience in lateral partner recruiting or executive search within a law firm or legal industry setting.
• Demonstrated success leading partner-level recruiting and integration initiatives at an AmLaw 200 or comparably sophisticated firm.
• Deep understanding of recruiting best practices, law firm economics, practice management, industry trends and client development dynamics.
• Exceptional interpersonal, communication, analytical and negotiation skills, with the ability to influence and build trust across all levels.
• Strategic mindset combined with a hands-on, collegial approach consistent with Goulston & Storrs' culture.
• Proactive, outgoing and client-service oriented personality with growth mindset, professional, positive demeanor and work style.
• Commitment to professionalism, confidentiality, and the firm's values of collaboration, inclusion, and excellence.

About Goulston & Storrs

Goulston & Storrs is a modern, forward-thinking AmLaw 200 firm with a collaborative culture and a commitment to client service excellence. We combine deep industry knowledge with practical, relationship-driven lawyering across real estate, corporate, litigation, and private client practices. The firm's success is built on teamwork, respect, and a genuine investment in its people — making it a distinctive environment for professionals who thrive in a collegial and high-performing setting.

The salary range for this position is $220,000 to $270,000 annually, depending on qualifications and experience.

Goulston & Storrs provides equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, marital status, national origin, age, handicap, disability or veteran status in accordance with applicable state and federal laws. In addition, Goulston & Storrs complies with applicable federal, state and local laws governing nondiscrimination in employment.

Currently looking for an experienced Executive System Director of Pharmacy at a 300 Bed acute care hospital in Louisiana. Interested candidates should have 5+ years of recent DOP experience in a large hospital with multi-site experience.

Responsibilities of the Health System Director of Pharmacy

• The Planning, Supervising, Controlling and Organizing within the pharmacy according to the hospital policies
• Recommend innovations to pharmacy and hospital administration
• Will oversee Pharmacy Operations for the main large hospital including 20 Pharmacists, 20+ Pharmacy Technicians as well as an Assistant Director and Clinical Pharmacy Manager and two additional hospitals in the system.

Requirements of the System Director of Pharmacy

• BS or Pharm D
• 3+ years of recent Pharmacy Director level experience in a multiple hospital/health system
• Specialty pharmacy knowledge is a plus
• 340B experience

For more information on this System Director of Pharmacy position or other Pharmacy roles nationwide, please send us your updated resume for review.

HOT

Currently looking for an experienced Executive System Director of Pharmacy at a 300 Bed acute care hospital in Louisiana. Interested candidates should have 5+ years of recent DOP experience in a large hospital with multi-site experience.

Responsibilities of the Health System Director of Pharmacy

• The Planning, Supervising, Controlling and Organizing within the pharmacy according to the hospital policies
• Recommend innovations to pharmacy and hospital administration
• Will oversee Pharmacy Operations for the main large hospital including 20 Pharmacists, 20+ Pharmacy Technicians as well as an Assistant Director and Clinical Pharmacy Manager and two additional hospitals in the system.

Requirements of the System Director of Pharmacy

• BS or Pharm D
• 3+ years of recent Pharmacy Director level experience in a multiple hospital/health system
• Specialty pharmacy knowledge is a plus
• 340B experience

For more information on this System Director of Pharmacy position or other Pharmacy roles nationwide, please send us your updated resume for review.

HOT