Regulatory Affairs Specialist

Remote • Posted 60+ days ago • Updated 12 days ago
Part Time
No Travel Required
Remote
Depends on Experience
Fitment

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Job Details

Skills

  • Regulatory Affairs
  • Pharmaceutics
  • Biotech pharma
  • Management
  • Project Management

Summary

Position: Senior Manager, Regulatory Affairs
Location: Remote
We are seeking an experienced Senior Manager, Regulatory Affairs to support global regulatory activities and key submission deliverables for our growing biotech organization. This role is well-suited for someone who is hands-on, highly organized, and comfortable working in a lean, fast-paced environment.

Key Responsibilities
  • Support global regulatory strategy and execution for U.S. and ex-U.S. programs.
  • Lead and coordinate IND/CTA submissions, protocol amendments, and responses to health authority queries.
  • Manage submission timelines, tracking tools, and cross-functional project coordination.
  • Collaborate closely with Clinical, CMC, Nonclinical, and external vendors to ensure high-quality regulatory deliverables.
  • Assist with document authoring, QC review, and submission-readiness activities.
  • Knowledge of U.S. regulatory submissions and eCTD format is strongly preferred.

Requirements
  • 3+ years of Regulatory Affairs experience within biotech or pharma.
  • Experience preparing and supporting U.S. submissions (INDs, amendments, meeting packages).
  • Strong project management skills with the ability to drive timelines and deliverables.
  • Ability to work independently and effectively within a small, dynamic biotech environment.
  • Excellent communication, organizational skills, and strong attention to detail.
  • Biological logic development
  • An important requirement is a small-molecule drug development experience.

Thanks

Vimal Jeeva

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: jeanmart
  • Position Id: 8837265
  • Posted 30+ days ago
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