Director/Senior Director- Regulatory Affairs

Job: Director/Senior Director, Regulatory Affairs

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

• Bachelor’s degree in a scientific discipline (e.g., Chemistry, Biochemistry, Molecular Biology, Biotechnology, Biology, Pharmacy); advanced degree preferred.
• Minimum of 7 years of regulatory affairs experience within pharmaceutical or biotech clinical development; experience in oncology and autoimmune areas desirable.
• Strong understanding of FDA, EMA, and ICH regulations, with demonstrated proficiency in regulatory submissions and approval processes.
• Proven track record of achieving regulatory milestones throughout development and registration phases.
• Experience leading communications and negotiations with regulatory agencies.
• Ability to guide cross-functional teams and collaborate effectively with CRO partners.
• Exceptional attention to detail and adherence to established procedures.
• Highly organized, self-directed, and able to work effectively within a collaborative environment.
• Strong decision-making skills and the ability to think creatively while upholding regulatory and quality standards.
• Skilled in identifying and communicating critical issues to senior management.
• Capable of managing conflict and fostering productive relationships with internal and external stakeholders.
• Strong sense of ownership for program success and flexibility in supporting evolving needs.
• Willingness to work flexible hours, including occasional calls with teams in other time zones.

Offer:

• Competitive salary ($200-300k)
• Professional development and potential for upward career growth.
• Impact in shaping regulatory strategy.