Talent.com
No longer accepting applications
Senior Manager / Associate Director Regulatory Affairs

Senior Manager / Associate Director Regulatory Affairs

Vivid ResourcingPrinceton, NJ, US
3 days ago
Job type
  • Full-time
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.
    • Create a job alert for this search

    Director Regulatory • Princeton, NJ, US