Connecting linkedin

W1siziisimnvbxbpbgvkx3rozw1lx2fzc2v0cy9oyw1sew4td2lsbglhbxmvanbnl2jhbm5lci1kzwzhdwx0lwpvyi5qcgcixv0

Job

Associate Director, Regulatory Affairs

  • Location

    South San Francisco, CA, USA

  • Sector:

    Life Sciences

  • Job type:

    Permanent

  • Contact:

    Nikita Madan

  • Contact email:

    n.madan@hamlynwilliams.com

  • Salary high:

    0

  • Salary low:

    0

  • Published:

    7 months ago

  • Expiry date:

    2020-07-18

  • Startdate:

    ASAP

Our client, a clinical-stage biopharmaceutical comapny based in San Francisco is looking to hire a senior level Regulatory Affairs professional. This Associate Director will help to develop and implement global regulatory strategies encompassing clinical, non-clinical and CMC disciplines to guide the development of multiple early development and late development drug candidates.

Role:

  • To lead the preparation, assembly, review and submission of regulatory documentation such as INDs, IMPDs, orphan drug applications, annual reporting and pediatric plans.
  • You will represent the Regulatory Affairs function in senior management meetings for regulatory strategies and aid the development of early and late stage development programs.
  • You will focus on the execution of regulatory strategy with the help of cross-functional project teams and will also be required to interaction with global health authorities and corporate partners when required.
  • You will be expected to lead the strategy and prepare for Health Authority meetings and also to serve as the primary liaison with Health Authority for assigned projects.
  • Generally manage and build the regulatory group and manage the work of others by providing guidance to their teams.

Experience needed

  • Bachelor’s degree in a life sciences, chemistry, or related discipline, an Advanced degree is highly preferred.
  • 10+ years’ worth of experience in Regulatory Affairs.
  • Experience working with US health authorities.

 

If this opportunity interests you, please get in touch!