More jobs:
Sr. Regulatory Affairs Professional, Global TA
Job in
Clifton, Passaic County, New Jersey, 07015, USA
Listed on 2026-09-14
Listing for:
Scorpion Therapeutics
Full Time
position Listed on 2026-09-14
Job specializations:
-
Pharmaceutical
Regulatory Compliance Specialist
Job Description & How to Apply Below
Role:
Sr. Regulatory Affairs Professional, Global TA supporting innovative medicine programs across diverse therapeutic areas and development stages.
Responsibilities
- participate in global/regional regulatory teams
- advise on requirements
- prepare agency interactions
- ensure timely responses to agency queries
- review clinical and submission documents
- develop regulatory strategies
- support inspections/audits
- Collaborate cross-functionally
- stay informed on regulatory guidelines
- serve as secondary contact with Health Authorities
- Bachelor’s in a scientific discipline plus 6 years’ experience in academia or industry; or PharmD/PhD with 2+ years, or Master’s with 3+ years.
- Experience with drug development, regulatory submissions, and agency interactions preferred.
- Skills include regulatory strategy, compliance, project management, communication, and problem-solving.
- experience in regulated pharma/biotech environment
- understanding US/EMA guidelines
- life-cycle management
- cross-functional teamwork
Location:
Spring House, PA, Raritan, NJ, or Titusville, NJ; likely hybrid.
The role offers broad exposure to regulatory processes for early to late-stage drug development, supporting marketed products and pipeline compounds in a fast-paced, innovative setting.
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