Global Regulatory Director – Tactical Submissions

BioSpace

Radnor (Delaware County)

Hybrid

USD 190,000 - 235,000

Full time

6 days ago

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Job summary

Immunocore is seeking a Director of Regulatory Affairs for Tactical Implementation, based in Gaithersburg, MD and Radnor, PA. You will lead regulatory strategy, coordinate IND/CTA submissions, and liaise with Health Authorities to advance Immunocore’s development programs.

Ideal candidates will have senior experience in biologics, strong leadership, and the ability to operate in an agile, high-profile environment.

Qualifications

Solid track record in drug development and leadership within dynamic project teams.
Emerging understanding of global regulatory requirements to formulate tactical regulatory strategies.
Experience preparing and submitting regulatory documentation to ensure global compliance.
Excellent knowledge of US regulatory requirements and submissions in drug development.

Responsibilities

Provide regulatory leadership for cross-functional development to achieve strategic objectives.
Oversee delivery of US and EU regulatory submission activities across Immunocore portfolio.
Lead resource planning and training of direct reports within the regulatory team.
Co-ordinate and submit documentation for regulatory submissions to US and international authorities (CTA/INDs, BLAs/NDAs, MAAs).
Serve as regulatory center of excellence, tracking changes in laws and guidelines impacting tactics.