San Francisco, CA, USA
about 1 year ago
My client is a highly innovative and rapidly growing biopharmaceutical company that specializes in products for the Endocrinology therapeutic area. My client is looking to hire a Project Manager, Regulatory Affairs Operations to facilitate the submissions of the license as well as driving on-time execution for the regulatory filing.
This person wil:
- Coordinate preparation of Clinical sections of BLA for the lead candidate, under the leadership of the Senior Medical Director, Clinical Development and the Chief Medical Officer.
- Create a project plan to compile all components of the BLA filing: define the process, timelines, owners, reviewers, and interdependencies of these components.
- Follow-up with owners and reviewers to ensure on-time execution.
- Define critical path and at-risk activities, anticipate bottlenecks, and clear barriers to progress.
- Drive a gap analysis of BLA-enabling activities, with a focus on Clinical.
- Collaborate closely with the Preclinical, Bioanalysis, and Product Development departments, all of which will make significant contributions to the BLA filing also.
-Build project plans for other regulatory filings
This person will have:
- Experience with BLA/NDA submissions to FDA
- BA/BS degree required; advanced degree preferred
- 5+ years in project management in R&D drug development
- Pharmaceutical R&D drug development knowledge
- Direct experience in, or collaborative partnership with multiple functions e.g., Clinical Development, Clinical Operations, Regulatory Affairs, Medical/Regulatory Writing
- PMP certification preferred
- Exceptional interpersonal skills (including cultural sensitivity) and assertive-yet-diplomatic communication skills (including presentations, written communications)
Strong leadership skills, including ability to lead colleagues across line organizations outside of reporting relationships
- High level of organizational skills and attention to detail
- Ability to travel up to 10% of the time domestically and internationally