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Regulatory Affairs Specialist Team Lead

5+ years
Not Disclosed
12 May 21, 2024
Job Description
Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Communication Skills, CPC Certified, ICD-10 CM, CPT, HCPCS Coding, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Job Title: Regulatory Affairs Specialist Project Lead


Work Schedule:

  • Shift: 1st shift (8am-5pm)
  • Days: Monday to Friday
  • Location: Bridgewater, NJ
  • Contract Length: 3 Months 4 Days

Description:

Sanofi's contingent workforce program, FLEXT Direct, is seeking a Regulatory Affairs Specialist Project Lead for a 3-month, 4-day contract. This role requires direct experience in US FDA Advisory Committee (ADCOM) Preparation, with preference given to candidates with experience in Immunology products.


Top Must-Haves:

  1. ADCOM Preparation Experience:
    • Preparing for the advisory committee, including slide preparation for potential questions.
    • Understanding how the FDA asks questions and preparing the team to respond effectively.
  2. Regulatory Affairs Experience:
    • Minimum 5 years of relevant Regulatory Affairs experience, regionally and/or globally.
  3. Direct Experience in US FDA ADCOM Preparation.

Nice to Have/Preferred:

  • Previous Regulatory Experience: As a Consultant, Director, or Global Regulatory Affairs Specialist.

Experience:

  • Years of Experience: At least 8-10 years of relevant pharmaceutical/biotechnology experience in R&D.
  • Regulatory Affairs Experience: Minimum 5 years of relevant Regulatory Affairs experience, regionally and/or globally, with direct experience in US FDA ADCOM Preparation.

Education:

  • Degree: BS/BA degree in a relevant scientific discipline required.
  • Advanced Degree: Preferred (PharmD, PhD, MD, DVM, or MSc in Biology, Life Science, or related field).