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Regulatory Affairs Specialist

New

Skills

BLA submissions CMC (Chemistry, Manufacturing, and Controls) CTA submissions IND submissions MS Office Suite NDA submissions Organizational skills Project management Regulatory Affairs Written communication

The Regulatory Affairs Specialist will serve as the regulatory CMC representative on project teams, ensuring compliance and clarity in regulatory submissions. This remote position offers opportunities for professional development while supporting critical regulatory filings.

Key Responsibilities
  • Review proposed CMC changes and assess regulatory impact.
  • Support regulatory filings including INDs, CTAs, BLAs, and NDAs.
  • Collaborate on submission content to ensure regulatory clarity.
  • Ensure timely preparation of organized and scientifically valid applications.
  • Travel up to 15% may be required.
Required Skills & Qualifications
  • Bachelor's degree in Chemistry, Biology, Pharmaceutical Science, or a related field.
  • Proficient in MS Office Suite (Word, Excel, PowerPoint, Outlook).
  • 0-2 years of experience in Regulatory Affairs.
  • Strong written and verbal communication skills.
  • Excellent organizational and interpersonal skills.
  • Experience with regulatory submissions and lifecycle management.
  • Ability to travel up to 15%.

No forms. Your profile is generated instantly.

Job Type: Remote

Salary: Not Disclosed

Experience: Entry

Duration: Months

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