Position Overview:
City Therapeutics is seeking a Director, Regulatory Affairs – Global Regulatory Lead (GRL) who will lead global regulatory strategy and execution for assigned products across all phases of development and commercialization. Reporting to the SVP, Head of Regulatory Affairs, this full-time onsite role is critical to guiding cross-functional teams, managing health authority interactions, and ensuring regulatory compliance to support product approvals and lifecycle management.
Key Responsibilities:
Strategic Leadership:
- Serve as the Global Regulatory Lead on cross-functional teams.
- Develop and execute global regulatory strategies across development stages.
- Provide input into clinical, CMC, nonclinical, and labeling strategies.
- Anticipate regulatory risks and lead mitigation planning.
Health Authority Engagement:
- Lead FDA, EMA, MHRA, and global health authority interactions.
- Oversee briefing documents, regulatory responses, and major submissions (e.g., IND, CTA, NDA, BLA, MAA).
Regulatory Submissions & Compliance:
- Manage timely preparation and quality of global regulatory submissions.
- Ensure compliance with global regulations and evolving requirements.
- Contribute to regulatory operations, including QC, publishing, archiving, and correspondence tracking.
Cross-Functional Collaboration:
- Act as the regulatory contact for development teams, CROs, and partners.
- Provide regulatory support for business development and due diligence.
- Contribute to shaping external regulatory policy through industry engagement.
Qualifications:
Education:
- Advanced degree (Ph.D., Pharm.D., or equivalent) in Life Sciences or Pharmacy.
Experience:
- 10+ years in biopharma, with 6+ years in Regulatory Affairs.
- Full product lifecycle experience (First-in-Human through commercialization).
- Proven success leading global submissions and regulatory approvals.
- Experience with siRNA or ASO modalities is a plus.
- Familiarity with small/start-up biotech environments preferred.
Skills & Attributes:
- Deep understanding of global regulatory requirements and strategy.
- Strong leadership, communication, and influencing abilities.
- Strategic, hands-on, and results-oriented.
- Skilled in project management and cross-functional collaboration.
- Able to navigate complex regulatory landscapes with agility.
Job sourced from City Therapeutics.