Director, CMC Regulatory Affairs

Job Title: Director, CMC Regulatory Affairs

Job Number: 37310

Location: San Diego, CA

The Director, Regulatory Affairs CMC will provide Regulatory Affairs CMC leadership for development teams throughout the development program (discovery, development, submission, approval and post-approval). This person will be responsible for the development of efficient and effective CMC regulatory strategies and in the implementation of those strategies to achieve commercial status and lifecycle success.

• Build strong regulatory intelligence to guide the creation of effective, globally aligned CMC regulatory strategies.
• Execute the established regulatory strategies to support product development and approval.
• Develop and apply appropriate tactics, collaborating with internal teams and external partners, to secure the earliest possible regulatory approvals.
• Serve as the company’s lead CMC regulatory representative within corporate alliance teams to help achieve partnership goals.
• Act as the primary contact in communications and negotiations with domestic and international regulatory authorities.
• Oversee the coordination, preparation, drafting, and submission of regulatory documents and applications.
• Lead regulatory CMC activities for key programs, ensuring alignment and collaboration across functional areas during filings.
• Identify and address critical regulatory considerations related to manufacturing, testing, quality control, and preclinical and clinical development, ensuring compliance with U.S. and global regulations.
• Manage and mentor team members when applicable, supporting both their professional growth and organizational objectives.
• Perform additional responsibilities as required.

• Bachelor’s degree required in Pharmacy, Chemistry, Biochemistry, Pharmaceutical Sciences, or a related biological/biomedical field.
• An advanced degree (Master’s or PhD) and RAC certification (or equivalent) are strongly preferred.
• Minimum of 10 years of relevant experience within the biopharmaceutical industry.

• Experience working in a small or emerging biotech environment is advantageous.
• Demonstrated leadership involvement in both U.S. and global regulatory submissions.
• Solid understanding of FDA and EMA regulations, pharmacopeial standards, regulatory authorities, and approval pathways.
• Proven success in establishing and maintaining productive relationships with regulatory agencies.
• Ability to strategically apply regulatory expertise to drive competitive advantage.
• Experience leading the preparation, coordination, and positioning of CMC components for development‑stage submissions (e.g., IND, IMPD) and marketing applications (e.g., NDA, MAA).
• Strong history of successful regulatory filings for drug and peptide therapeutics, including INDs, IMPDs, NDAs, MAAs, annual reports, amendments, and supplements.
• Advanced proficiency in Microsoft Office (Word, PowerPoint, etc.), Outlook, internet‑based tools, and virtual meeting platforms such as Web Ex and Zoom.
• Exceptional attention to detail with strong proofreading and editing capabilities.
• Excellent analytical, interpersonal, and problem‑solving skills, with the ability to collaborate effectively.
• Skilled at managing multiple priorities while maintaining professionalism and accuracy.
• Self‑driven and entrepreneurial mindset, with confidence and a positive outlook.
• Reliable and committed, willing to go above and beyond to meet objectives.
• Strong team orientation with outstanding written and verbal communication skills.

Compensation: $,000 USD plus benefits