Cpl Life Sciences

Regulatory Director

San Francisco
30 Apr 2021
30 May 2021
Rhianna Bellamy
Regulatory Affairs
Full Time
Contract Type
Experience Level
Senior Management

Regulatory Director
Location: San Francisco or Boulder

My client is an exciting commercial stage biotechnology company who are focused on the acquisition, development, and commercialisation of cancer treatments. They operate within the United States and Europe as well as other international markets. Their patients are at the heart of everything they do as they strive to make a difference in peoples lives. The company have a strong pipeline for the future and are keen to bring a new Regulatory Director on board to help them achieve their potential.

The successful applicant will be joining a Regulatory team of 4 as an individual contributor. They are looking for someone who is highly experienced with the FDA and working within early development Oncology products.

Key responsibilities:
-Representing Regulatory Affairs on global project teams, sub-teams and in joint alliances as required
-Directing all aspects of regulatory support and strategy for the global project team on the designated products
-Leading, facilitating and coordinating regulatory meetings for the assigned projects
-Being the primary FDA contact for assigned projects
-Initiating and updating regulatory strategic plans for the projects and coordinating with the project leader for incorporation into a product development plan
-Preparing and/or directing and submitting all the required submissions to FDA in support of clinical trials and marketing applications
-Ensuring the project team objectives and timelines are supported by regulatory deliverables

-Minimum of BS in a relevant scientific discipline, advanced degree, or RAC certification preferred
-A broad understanding of drug development
-Competency in FDA regulatory requirements
-Experience in communicating with FDA or other health authorities in written and verbal formats
-Experience serving on a project team

If you would like to hear more, please apply within or send your CV to Rhianna.bellamy@cpl.com

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