Director, CMC Regulatory Affairs

Vir Biotechnology•San Francisco, CA

2d•Hybrid

About The Position

Vir Biotechnology is seeking a highly motivated, self-driven, and enthusiastic Director of Regulatory CMC accountable for ensuring all assigned products have a successful regulatory CMC strategy for clinical development and commercialization. This role requires a track record of successful regulatory submissions demonstrating core capability in technical (CMC) development, as well as a passion to challenge conventional paradigms and influence global Health Authorities. The ideal candidate will contribute to a culture of high performance, empowerment, continuous learning, and diversity and inclusion. This position will work closely with the Technical Operations (CMC) functional groups and Regulatory Affairs department to plan and lead high-quality regulatory submissions to health authorities. This role is located in our San Francisco headquarters with an expectation of 3 days per week in office.

Requirements

B.S., M.S., Ph.D. or other relevant advanced degree or certificate.
10+ years experience in pharmaceutical product development including strong global Regulatory CMC leadership.
Regulatory CMC experience leading both development projects (IND/CTA) and initial registration (BLA/MAA).
Experience with CMC regulatory considerations for late stage and/or commercial large molecules (biologics) is required.
Thorough understanding of major FDA, EMA, ICH, EudraLex CMC guidelines.
Global clinical filing experience (US, EU, UK, CA).

Nice To Haves

Experience with combination product or oligonucleotide experience is a plus.
Preference will be given to candidates with recent experience with initial BLA and/or NDA (CMC sections).
Management of US post-market, biologic product CMC changes is a plus.
Experience with Health Authority interactions is desirable.
Working knowledge of other global clinical territories procedures a plus.

Responsibilities

Provide strategic CMC regulatory leadership to develop and execute sound regulatory strategies that meet global regulatory requirements and enable Vir business objectives.
Provide CMC regulatory expertise to enable global development and registration for INDs, CTAs, BLAs and MAAs.
Identify and communicate regulatory risks and facilitate the development and execution of risk mitigation strategies in concert with Technical Operation functions.
Plan strategy for and lead HA interactions for CMC specific issues.
Manage CMC regulatory changes throughout the product life cycle, including support for relevant quality systems related to change control, discrepancy management, as well as Health Authority inspection support (as applicable).
Ensure overall dossier compliance with regulatory requirements.
Ensure compliance with internal SOPs and policies.
Contribute to regulatory excellence by identifying opportunities and supporting continuous improvement.