Associate Director Regulatory Affairs

Associate Director I Therapeutics I Head of DE&I at Skills Alliance

About the Role

The Associate Director / Director, Regulatory Science will serve as a key member of the Regulatory team, responsible for developing and executing global regulatory strategies and ensuring timely preparation and submission of regulatory filings to support clinical development programs worldwide.

This position is a technical, individual contributor role with broad cross‑functional impact, working closely with internal development teams and external partners. The successful candidate will guide regulatory decision‑making across development stages and contribute to both clinical and CMC regulatory activities for an expanding oncology portfolio.

Key Responsibilities

• Oversee Clinical Trial Submissions : Coordinate and oversee the preparation of clinical trial applications across multiple regions (e.g., United States, Asia‑Pacific, and Europe). Ensure submissions are complete, timely, and compliant with relevant regulations. Support applications for designations such as Fast Track, Breakthrough Therapy, or Orphan Drug status.
• Hands‑On Implementation : Draft, review, and coordinate regulatory documents with precision and efficiency. Combine strategic oversight with direct, executional involvement.
• Lifecycle Maintenance of Submissions : Manage post‑submission activities, including amendments, protocol and investigator brochure updates, and general IND / CTA maintenance.
• Vendor Oversight : Manage regulatory vendors (e.g., CROs, publishers, consultants), ensuring high‑quality deliverables aligned with internal expectations and timelines.
• Adaptability and Problem‑Solving : Operate effectively within a dynamic, fast‑paced environment where roles and priorities may evolve.
• Cross‑Functional Collaboration : Partner closely with internal teams—clinical operations, medical, safety, CMC, and nonclinical—to align regulatory activities with overall program goals and timelines.

Essential Qualifications

Seniority level

Employment type

Job function

Industries

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