Director, Regulatory Affairs
Posted on Apr 6, 2021 by Clovis Oncology, Inc.
Represent Regulatory Affairs on global project teams, subteams and in joint alliances as required. Direct all aspects of regulatory support and strategy for the global project team on the designated product(s).
Lead, facilitate and coordinate regulatory meetings for the assigned project(s). This may include internal meetings, meetings with partners and/or meeting with regulatory agencies (in particular FDA)
Responsible for being primary FDA contact for assigned project.
Initiate and update regulatory strategic plans for the projects and coordinate with the project leader for incorporation into a product development plan. Assess pros, cons and risks of the various strategic options and communicate to the project team and management.
Prepare and/or direct, and submit all the required submissions to FDA in support of clinical trials and marketing applications. Review and approve all documents used in regulatory submissions (including protocols and reports).
Ensure the project team objectives and timelines are supported by regulatory deliverables.
Keep abreast of all pertinent laws, regulations and guidance relevant to oncology and the specific product areas.
Provide expertise in the interpretation of regulations and guidance relating to product development and other regulatory requirements.
Coordinate with European/ROW Regulatory Affairs group for global regulatory strategy and submissions.
Appoint and manage consultants and contractors as required.
Broad understanding of drug development and experience in oncology and/radiotherapeutics preferred
Competency in FDA regulatory requirements is essential. Global experience is a plus
Experience in communicating with FDA or other health authorities in written and verbal formats, both informally and in formal meetings.
Excellent verbal and written skills
Flexible mindset and ability to multitask
Education and Experience
Minimum of BS in a relevant scientific discipline, advanced degree, or RAC certification preferred
Strong scientific background
At least 8-10 years US regulatory affairs experience and at least 10-12 years total pharmaceutical industry experience.
Experience serving on a project team
The salary range for this position is $160,000 - $230,000.
Office-based, up to approximately 30% travel
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