Compliance

• 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

Senior Manager, Regulatory Affairs

Job Level

About the role

Requirements