Regulatory Affairs Director

Location: Remote
Compensation: Salary
Staff Reviewed: Wed, Feb 07, 2024
This job expires in: 5 days

Job Summary

A biotechnology company is looking for a Regulatory Affairs Director.

Responsibilities:
  • Provide guidance and support to regulatory affairs' team members and cross-functional teams
  • Advise and assist cross-functional teams on regulatory strategies to optimize and expedite the development and maximize the probability of success
  • Develop, maintain, and communicate timelines for regulatory submissions to ensure timely delivery of regulatory documentation
Qualifications:
  • Advanced degree (M.S., Pharm.D., Ph.D.) or B.S. Degree in Biology, Immunology, or related field
  • Minimum of 7 years of relevant regulatory affairs experience with an advanced degree or 12 years with a Bachelor's degree, with proven strategic involvement with small molecule drugs and/or biologics development
  • Rare Disease experience required; late-stage development for rare diseases is highly desirable
  • Experience with a successful US NDA submission experience in rare disease
  • Thorough understanding and demonstrated experience with eCTD submission requirements, utilizing document templates, and knowledge of global operational regulations and guidelines

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