Connecting linkedin

W1siziisimnvbxbpbgvkx3rozw1lx2fzc2v0cy9oyw1sew4td2lsbglhbxmvanbnl2jhbm5lci1kzwzhdwx0lwpvyi5qcgcixv0

Job

Manager, Regulatory Affairs

  • Location

    Greater Philadelphia Area

  • Sector:

    Life Sciences

  • Job type:

    Permanent

  • Contact:

    Marissa Saunders

  • Contact email:

    m.saunders@hamlynwilliams.com

  • Salary high:

    0

  • Salary low:

    0

  • Published:

    7 months ago

  • Expiry date:

    2020-04-11

A biopharmaceutical company of ours has a new opening for a Manager of Regulatory Affairs role located in the Greater Philadelphia area. This individual will be responsible for ensuring activities for the US are complete and assisting with EU/ROW registration activities by supporting all regulatory functions and contributing to ongoing development activities.

Responsibilities

  • Prepare IND and NDA submissions, clinical trial applications, amendments, safety updates, meeting requests, briefing packages, supplements, annual reports, etc.
  • Document regulatory activities with all Health Authorities such as the FDA
  • Participate as an active member of a multi-disciplinary team to develop regulatory strategies for late stage and early development programs as well as commercialized products
  • Identify potential risks associated with regulatory strategies
  • Provide in depth review of protocols, reports, presentations, and other regulatory documents
  • Assist in managing internal review of all submissions and documents
  • Ensure completeness, accuracy, and consistency adhering to all regulations and guidelines for submissions

Requirements

  • At least 5 years of regulatory experience
  • Understanding of regulations, guidelines, and strategic application for drug development at IND and NDA stages
  • Experience with eCTD submissions
  • Excellent verbal and written communication skills

This role is actively interviewing candidates, please send your CV to Marissa, at  m.saunders@hamlynwilliams.com for consideration.