Job Description
Job Description
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
- Bachelor’s degree in a scientific discipline (e.g., Chemistry, Biochemistry, Molecular Biology, Biotechnology, Biology, Pharmacy); advanced degree preferred.
- Minimum of 5 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 ($150-200k)
- Professional development and potential for upward career growth.
- Impact in shaping regulatory strategy.
Job Tags
Flexible hours,