This San Diego biotechnology company is focused on novel biological and drug delivery technologies. They are seeking a Regulatory CMC Director that can develop and execute on regulatory CMC strategies for assigned partner programs, and manage junior-level staff. You will work closely with cross-functional teams to ensure the timely submission of regulatory filings for investigational products, marketing applications, and post-approval changes. This is a remote role with some occasional travel. This is an exciting opportunity to broaden your experience across clinical, non-clinical, and CMC regulatory in a fun, dynamic, and patient-focused organization!
- Contribute to and execute on regulatory CMC strategies for a portfolio of partnership programs including development and approved products.
- Work directly with biopharma partners on regulatory issues.
- Plan, write and review DMFs and CMC sections for INDs, CTAs, NDAs, BLAs, amendments, and life-cycle management submissions.
- Conduct post-approval CMC regulatory activities such as change controls, etc.
- Provide regulatory support and advice for internal and external customers in line with defined regulatory plans and in response to ad-hoc questions.
- Conduct external and internal audits, document control, release of products, management reviews, complaint management, inspection liaison, annual reviews, and validations.
- Manage a small team of direct reports and serve as a key member of the management team.
- Participate in identifying and implementing the tactics necessary to achieve timely submissions and product approvals and maintain a positive quality profile .
- BS. in a scientific discipline; advanced degree (MS, PhD, Pharm D) preferred.
- 8+ years of experience in Regulatory CMC for pharmaceutical drugs and/or biologics.
- Experience writing and managing DMFs and CMC sections of INDs, CTAs, BLAs, and/or MAAs for biologic programs.
- Experience with life cycle management and post-approval CMC changes.
- Global regulatory experience a plus but not required.
- Solid knowledge of FDA, EMA and ICH CMC guidelines and regulations and current Good Manufacturing Practices (cGMP).
- Experience in supervising junior staff and supporting their development preferred, but not required.
- Energetic person with ability to prioritize and work on multiple projects at the same time.
- Strong oral and excellent written communication skills.
- Creative approach to problem solving; ability to deal with ambiguity and define a clear path forward.
- Strong organizational skills and attention to detail.