Regulatory Affairs Project Manager

Remote in Jersey City, NJ, US • Posted 15 hours ago • Updated 13 hours ago
Contract W2
On-site
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Job Details

Skills

  • Pharmaceutics
  • Regulatory Compliance
  • Pharmacy
  • Life Sciences
  • Chemistry
  • Regulatory Affairs
  • Pharmaceutical Industry
  • NDA
  • GMP
  • GxP
  • Project Management
  • Collaboration
  • Communication
  • Stakeholder Management
  • SANS

Summary

Job Title: Regulatory Affairs Project Manager - Small Molecule (20 Hrs/Week)

Location: Remote

Job Description

We are seeking an experienced Regulatory Affairs Project Manager with strong expertise in Small Molecule pharmaceutical products. The ideal candidate will lead regulatory submission activities, coordinate cross-functional teams, and ensure compliance with global regulatory requirements.

Required Skills & Qualifications

  • Bachelor s or Master s degree in Pharmacy, Life Sciences, Chemistry, or related field.
  • 10+ years of Regulatory Affairs experience in the pharmaceutical industry.
  • Strong experience with Small Molecule products.
  • Hands-on experience with IND, NDA, and ANDA submissions.
  • Knowledge of FDA, EMA, ICH, GMP, and GxP guidelines.
  • Experience in regulatory project management and cross-functional coordination.
  • Strong communication and stakeholder management skills.
  • Experience with eCTD submissions and regulatory systems/tools.

Employers have access to artificial intelligence language tools (“AI”) that help generate and enhance job descriptions and AI may have been used to create this description. The position description has been reviewed for accuracy and Dice believes it to correctly reflect the job opportunity.
  • Dice Id: 10236892
  • Position Id: OOJ - 5010-4011-1779215444
  • Posted 15 hours ago
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