Senior Manager / Associate Director Regulatory Affairs (Princeton)

Job : Regulatory Affairs (Senior Manager / Associate Director)

Location Princeton, NJ

Our client is currently on the lookout for a Regulatory Affairs expert to be responsible for their US division.

Key Responsibilities

• Develop and lead global regulatory strategies for small-molecule and biologic programs supporting clinical development across oncology and autoimmune indications, from early-stage studies through registration.
• Oversee all regulatory submission activities, including planning, authoring, review, coordination, and delivery of documents for Pre-IND, IND, and marketing applications (NDA / BLA), as well as other lifecycle submissions.
• Ensure timely preparation of high-quality regulatory documentation and dossiers.
• Lead interactions with regulatory authorities, including setting meeting objectives, preparing briefing materials, coordinating internal rehearsals, and managing risk-mitigation plans.
• Collaborate closely with cross-functional teams to integrate regulatory considerations into program plans and ensure alignment with overall development timelines and objectives.
• Present and defend regulatory strategies in project team meetings and with external partners.
• Work with internal functions to ensure compliance with regulatory standards and support audit / inspection readiness.
• Maintain up-to-date knowledge of relevant regulatory guidelines, global requirements, and the evolving competitive landscape.
• Provide support across additional regulatory or program activities as needed.

Qualifications

Offer :