Director, Global CMC Regulatory Affairs (m/f/d)

Our client is a globally renowned healthcare organization committed to the research, development, and distribution of innovative products that address unmet medical needs. With a strong focus on improving health and well-being worldwide, this company emphasizes creativity, collaboration, and continuous pursuit of excellence across pharmaceuticals, nutraceuticals, and medical devices.

Core Responsibilities:

1. Proactively formulate and recommend robust strategies and contingency plans.
2. Provide expert guidance on regulatory and scientific/technical requirements for CMC and GMP-related submissions and inquiries for pharmaceuticals, medical devices, and combination products from regulatory bodies.
3. Tackle intricate challenges requiring a deep understanding of broader issues and specialized expertise in the CMC Regulatory Affairs domain.
4. Serve as a recognized authority and thought leader within the organization.
5. Oversee the preparation and review of all CMC and GMP-related documents, labels, and labeling for submission to regulatory authorities.
6. Ensure compliance with regulatory standards and scientific/technical criteria, and manage the approval process for these submissions.
7. Drive policies, practices, and procedures beyond your immediate role.
8. Cultivate collaborative relationships with CMC RA teams, manufacturing units, quality departments, R&D divisions, partners, technical operations, and other internal teams as well as external partners such as contract manufacturers, packagers, and suppliers.
9. Represent the organization at regulatory authority CMC meetings.
10. Lead strategic interactions and negotiations with regulatory authorities on CMC and GMP issues for products.
11. Stay informed of and provide guidance on current developments in guidelines, regulations, practices, and policies in CMC and GMP areas.
12. Conduct thorough regulatory assessments and provide input on Change Controls.
13. Review supporting data and reports, and update relevant computer systems as needed.
14. Demonstrate expertise with the necessary tools and systems for the job function (e.g., Reg Intel, EQMS, EDMS).
15. Actively engage in Project Teams, Clinical/Regulatory Teams, Global Regulatory Teams (GRTs), Submission Teams, and lead CMC GRTs and Submission CMC subteams.
16. Lead or participate in complex projects or programs of strategic importance, involving cross-functional teams such as early-stage R&D programs, due diligence, and in-licensing activities across a range of drug modalities (e.g., small molecules, peptides, oligos, proteins, etc.).
17. Manage direct reports and multiple contingent workers, providing leadership, coaching, and support.
18. Embody and promote the organization’s culture, acting as a cultural role model.
19. Assist with administrative leadership duties in CMC RA, including staffing, budgeting, documentation, SOPs, and communication with key internal and external stakeholders.

Key Requirements:

1. Possess a comprehensive understanding of the drug development process, pharmaceutical technology, drug manufacturing processes, GMP, and related issues.
2. Advanced knowledge and skills in CMC Regulatory Affairs, with an understanding of adjacent areas and industry practices, typically obtained through a combination of education and significant experience.
3. Thorough knowledge of FD&C Act, EMA & FDA quality guidelines, ICH, and regional compendial requirements, as well as EMA and FDA policies and practices for drugs, devices, and drug-device combinations.
4. Extensive experience in preparing CMC (Quality) sections for investigational and marketed product submissions (IND, NDA, DMF) for FDA and equivalent submissions for Europe (CTA, IMPD, MAA).
5. Comprehensive understanding of the global regulatory environment.
6. Proactive strategic thinker with an operational mindset, demonstrated by the ability to prepare high-quality technical documents or submissions using internal systems.
7. Exceptional analytical, problem-solving, organizational, and negotiation skills.
8. Strong interpersonal, communication, presentation, and meeting-leading skills.
9. Proven ability to work effectively in a matrix environment and across cultural lines, influencing others outside of the functional area regarding policies, practices, and procedures.
10. Proficient computer skills, with experience working with the Microsoft suite of programs (Word, Excel, PowerPoint, and Outlook).
11. 9 to 12 years of CMC regulatory experience in the pharmaceutical industry, with a history of successful investigational filings and marketing application approvals as the CMC Regulatory lead.
12. Familiarity with regulatory environments in Asia-Pacific, Latin America, and Middle-Eastern countries is advantageous.
13. 3 to 5 years of hands-on pharmaceutical product development experience, including scale-up and technology transfer to manufacturing and/or manufacturing experience, is highly desirable.
14. Experience as a CMC Quality reviewer (assessor) with FDA or EMA is highly desirable.
15. Bachelor’s degree in Pharmaceutical Sciences or Chemistry or Pharm.D. A Master’s degree or Ph.D. in Pharmaceutics or Industrial Pharmacy, with a minor in Organic Chemistry or vice versa, is preferred.

What’s in it for you?

1. Innovative Work: Engage in cutting-edge work that emphasizes creativity, innovation, and impactful change.
2. Collaborative Atmosphere: Thrive in a dynamic, vibrant, and collegial environment with diverse, cross-functional collaboration.
3. Long-Term Stability: Enjoy long-term stability guided by visionary leadership.
4. Health Solutions: Contribute to the development of groundbreaking medicines for hard-to-treat diseases.
5. Comprehensive Support: Benefit from extensive information and assistance provided to healthcare stakeholders.
6. Significant Impact: Participate in work that significantly improves global health and allows you to see the tangible results of your efforts.
7. Competitive Compensation: Receive a market-oriented salary with additional benefits such as pension schemes, health subsidies, and financial incentives.
8. Employee Health Initiatives: Prioritize your well-being through comprehensive health programs focusing on nutrition, fitness, and prevention.
9. Professional Growth: Access opportunities for long-term, mutually beneficial cooperation and professional development.

#J-18808-Ljbffr