Connecting linkedin

W1siziisimnvbxbpbgvkx3rozw1lx2fzc2v0cy9oyw1sew4td2lsbglhbxmvanbnl2jhbm5lci1kzwzhdwx0lwpvyi5qcgcixv0

Job

Senior Director of Global Regulatory

  • Location

    San Diego

  • Sector:

    Life Sciences

  • Job type:

    Permanent

  • Salary:

    Competitive

  • Contact:

    Cortland Hotz

  • Contact email:

    c.hotz@hamlynwilliams.com

  • Salary high:

    0

  • Salary low:

    0

  • Published:

    10 months ago

  • Expiry date:

    2020-03-07

  • Startdate:

    January

The Senior Director of Global Regulatory will implement regulatory strategies to support achievement of clinical program goals. 

Lead Health Authority meetings associated with the program. Responsible for the program’s global regulatory plan and its execution.

Identify and assess regulatory risks associated with clinical development activities.

Development and oversight of submissions - INDs and CTAs globally.

Have significant influence on achievement of corporate and program objectives and key results.

Ensure that plans meet global regulatory requirements.

Must have significant experience w/US FDA regulations and knowledge of the drug development process.

15+ years of industry experience.