Director, CMC Regulatory Affairs
Vir Biotechnology, Inc.
June 26, 2026
Remote friendly (San Francisco, CA)
United States
Corporate Functions
Director of Regulatory CMC (Clinical Development & Commercialization)
Responsibilities:
- Provide strategic CMC regulatory leadership for global regulatory strategies supporting product development and business objectives.
- Enable global development/registration for INDs, CTAs, BLAs, and MAAs.
- Identify and communicate regulatory risks and support risk mitigation with Technical Operations.
- Plan and lead Health Authority (HA) interactions for CMC-specific issues.
- Manage CMC regulatory changes across the product lifecycle (change control, discrepancy management, and HA inspection support as applicable).
- Ensure overall dossier compliance with regulatory requirements; comply with internal SOPs/policies.
- Support continuous improvement in regulatory excellence.
Qualifications:
- B.S., M.S., Ph.D., or other relevant advanced degree/certificate.
- 10+ years in pharmaceutical product development with strong global Regulatory CMC leadership.
- Experience leading both development (IND/CTA) and initial registration (BLA/MAA).
- Knowledge of CMC considerations for late stage/commercial biologics; combination product or oligonucleotide experience is a plus.
- Preference for recent initial BLA/NDA (CMC sections) experience; US post-market biologic CMC change management is a plus.
- Health Authority interaction experience desirable.
- Thorough understanding of FDA, EMA, ICH, and EudraLex CMC guidelines.
- Global clinical filing experience (US, EU, UK, CA); other territories procedures a plus.
- Ability to present effectively to senior management.
Benefits (as stated):
- Expected salary range: $195,500–$272,500; bonus and equity; health and welfare benefits; non-accrual paid time off; holiday shut down; commuter benefits; 401K match; lunch each day in the office.
Responsibilities:
- Provide strategic CMC regulatory leadership for global regulatory strategies supporting product development and business objectives.
- Enable global development/registration for INDs, CTAs, BLAs, and MAAs.
- Identify and communicate regulatory risks and support risk mitigation with Technical Operations.
- Plan and lead Health Authority (HA) interactions for CMC-specific issues.
- Manage CMC regulatory changes across the product lifecycle (change control, discrepancy management, and HA inspection support as applicable).
- Ensure overall dossier compliance with regulatory requirements; comply with internal SOPs/policies.
- Support continuous improvement in regulatory excellence.
Qualifications:
- B.S., M.S., Ph.D., or other relevant advanced degree/certificate.
- 10+ years in pharmaceutical product development with strong global Regulatory CMC leadership.
- Experience leading both development (IND/CTA) and initial registration (BLA/MAA).
- Knowledge of CMC considerations for late stage/commercial biologics; combination product or oligonucleotide experience is a plus.
- Preference for recent initial BLA/NDA (CMC sections) experience; US post-market biologic CMC change management is a plus.
- Health Authority interaction experience desirable.
- Thorough understanding of FDA, EMA, ICH, and EudraLex CMC guidelines.
- Global clinical filing experience (US, EU, UK, CA); other territories procedures a plus.
- Ability to present effectively to senior management.
Benefits (as stated):
- Expected salary range: $195,500–$272,500; bonus and equity; health and welfare benefits; non-accrual paid time off; holiday shut down; commuter benefits; 401K match; lunch each day in the office.