Associate Director, Regulatory Affairs CMC

Responsibilities:
- Act as Regulatory CMC Lead for assigned programs, providing strategic guidance on complex Regulatory CMC topics.
- In close collaboration with the CMC team, plan, prepare, and submit high-quality CMC-related applications including INDs and CTAs globally.
- Communicate with regulatory agencies on CMC topics, as appropriate.
- Lead and support Health Authority meeting strategy and preparation for CMC topics.
- Assess proposed technical changes and provide strategic regulatory guidance to enable global implementation.
- Drive adherence to CMC regulatory guidelines relevant to transformative gene-based medicines.
- Participate in regulatory intelligence activities for global CMC regulations/guidance and provide regulatory advice to program teams.
- Build and maintain strong relationships with internal and external stakeholders.

Minimum Qualifications:
- Bachelor’s degree in biochemistry, chemistry, biology, or related pharmaceutical fields (including chemical engineering).
- Regulatory CMC experience with significant accomplishments:
- 12+ years (bachelor’s) or 10+ years (advanced degree) as Associate Director.
- Direct experience in Regulatory Affairs CMC for biologics/vaccines or cell and gene therapies (e.g., successful IND; leading health authority interactions on CMC topics).
- Working knowledge of FDA, EMA, and ICH regulations/guidance; ability to apply to Regulatory CMC strategies for novel products.
- Working knowledge of eCTD requirements for IND/IMPD/CTA/BLA/NDA/MAA.
- Exceptional verbal/written communication and organizational skills; ability to manage multiple priorities.

Preferred Qualifications:
- PhD in relevant field (highly desirable).
- Late-phase IND/CTA/GMO submission authoring; understanding of FDA/EMA requirements for dossier development.

Benefits (as stated):
- Base pay range: $165,000–$180,000+ bonus, equity and benefits.