Senior Manager, License Compliance
Tanium
Senior Manager, Regulatory Affairs
ICON plc
full-time
Posted on:
Location: 🇺🇸 United States
Visit company websiteJob Level
Senior
About the role
- Participate in multidisciplinary project teams to provide regulatory guidance and communicate regulatory goals.
- Provide guidance to teams on the content, format, style and architecture of IND, or CTAs (ex-US studies).
- Perform/manage critical analysis of data (clinical, preclinical and manufacturing) independently develop interpretations and conclusions.
- Perform reviews of clinical protocols and study reports to focus attention of deficient/missing items/explanations.
- Accountable for ensuring the completeness and accuracy of all regulatory submissions
- Supervisory responsibility for planning, preparation and submission of regulatory documentation
- Management of the planning, preparation and submission of Investigational New Drug Applications (INDs) and Biologic Licensing Applications (BLAs)
- Provide guidance/instruction to teams on the content, format, style architecture and timing of BLAs
- Assist with scientific writing and review of a BLA and evaluate conformance with regulatory requirements
- Continually monitor newly published FDA guidelines and international guidance documents in the context of new and ongoing developmental programs
Requirements
- 4+ years of pharmaceutical industry experience in regulatory affairs
- Strong background in Regulatory Affairs and a history of successful interactions with the Regulatory Agencies
- Candidate should have an M.D., Ph.D. or Pharm. D. degree or equivalent in work experience
