Regulatory Affairs Consultant

Overview

Remote
Depends on Experience
Full Time
No Travel Required

Skills

Regulatory Affairs
Pharmaceutics
Biotech pharma
Management
Project Management

Job Details

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

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