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Job

Project Manager, Regulatory Affairs Operations

  • Location

    San Francisco, CA, USA

  • Sector:

    Life Sciences

  • Job type:

    Permanent

  • Contact:

    Avita Broukhim

  • Contact email:

    a.broukhim@hamlynwilliams.com

  • Salary high:

    0

  • Salary low:

    0

  • Published:

    2 months ago

  • Expiry date:

    2019-09-15

  • Startdate:

    ASAP

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