Position Overview:
City Therapeutics is seeking a Director of CMC Regulatory Affairs who will lead global regulatory strategy and execution for Chemistry, Manufacturing, and Controls (CMC) across Olema’s development pipeline. Reporting to the SVP, Head of Regulatory Affairs, this role is responsible for developing submission strategies, ensuring regulatory compliance, managing global submissions, and serving as a key liaison with Health Authorities.
Key Responsibilities:
Regulatory Strategy & Leadership:
- Develop and lead global CMC regulatory strategies for development, approval, and lifecycle management.
- Provide guidance on CMC content for INDs, NDAs, BLAs, IMPDs, MAAs, supplements, etc.
- Influence internal CMC and manufacturing decisions with regulatory insights.
- Represent CMC Regulatory on cross-functional teams and in governance.
Submissions & Compliance:
- Prepare, review, and oversee high-quality CMC sections for global regulatory submissions.
- Lead Health Authority interactions, including meetings, responses, and inspections.
- Ensure compliance with FDA, EMA, MHRA, and ICH guidelines.
- Execute or oversee Regulatory Operations tasks (publishing, archiving, correspondence).
Cross-Functional Collaboration:
- Work closely with CMC, QA, Supply Chain, and Clinical teams.
- Track evolving regulatory requirements and shape internal and external regulatory strategy.
- Contribute to shaping health policy through industry engagement.
Candidate Profile:
Education:
- Bachelor’s in Chemistry, Pharmacy, Biology, Engineering, or related field required.
- Advanced degree strongly preferred.
Experience:
- 10+ years in biopharma, including 6+ years in Regulatory Affairs – CMC.
- Experience leading global CMC strategies and submissions across development stages.
- Direct experience with FDA, EMA, and other regulatory bodies.
- Familiarity with small molecules, ASOs, RNA-based therapies (siRNA strongly preferred).
- Prior biotech/start-up experience is a plus.
Skills & Competencies:
- Strong leadership, communication, and regulatory expertise.
- Ability to influence cross-functional teams and executives.
- Project management skills; thrives in a fast-paced, resource-limited environment.
- Hands-on, detail-oriented, and solutions-driven.
Job sourced from City Therapeutics.