Senior Manager/Associate Director Regulatory Affairs Job at Vivid Resourcing, Princeton, NJ

c3hTWWRhRXhFcStpditubk42ZDg2QzE3NHc9PQ==
  • Vivid Resourcing
  • Princeton, NJ

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,

Similar Jobs

West Virginia Staffing

New Car Dealership Detailer / General Housekeeping Job at West Virginia Staffing

 ...$16.00 per hour. Some Saturdays may be required but we are flexible with the schedule in general. Typically M-F. Complete vehicle detailing of new and traded vehicles. Basic housekeeping to include but not limited to sweeping and cleaning bathrooms, showroom and office... 

Wisconsin Staffing

GIS Intern Job at Wisconsin Staffing

 ...GIS Intern At TDS Telecom, our interns are the future of our company. We provide hands-on learning experiences in a real-world environment, helping you sharpen the skills and knowledge relevant to your field of study or career path. Our goal is to equip you for success... 

AVENTIS Homes

Interior Home Designer Job at AVENTIS Homes

 ...Full-Time | &##127959; Aventis Homes Design isnt just about pretty rooms. Its about...  ...looking for a creative, detail-obsessed Interior Designer to join our growing team.You...  ...Order): Have 3+ years of professional experience in residential interior design (custom... 

Illinois Staffing

3rd Shift Packer (Bilingual) Job at Illinois Staffing

 ...Essential Skills Experience in packing and assembly. Ability to lift 30 pounds regularly....  ...with clean room protocols and medical assembly. Why Work Here? This opportunity...  ...for up to 11 hours a day in a medical device company setting. Job Type & Location... 

Awesome Travel Adventures

Travel Agents at Awesome Travel Adventures Woodland, MS Job at Awesome Travel Adventures

Overview Travel Agents job at Awesome Travel Adventures. Woodland, MS. Job Opportunity: Remote self-employed position.About Us: We are...  ...direct communication with suppliersQualifications No prior experience is necessary; comprehensive training will be providedAbility...