Regulatory Affairs Manager

3 weeks ago


San Francisco County, United States EPM Scientific Full time

ABOUT:

Are you passionate about advancing treatments for life-changing conditions? This global specialty pharmaceutical leader is transforming the landscape of genetic, metabolic, and systemic disorders. With a cutting-edge focus on melanocortin technology, they are on a mission to build a world-class melanocortin house-bringing hope to patients with life-threatening and acute conditions. With 10 products in the pipeline, ranging from pre-clinical to commercial, the company is looking to bring on a Regulatory Manager to their US site (California; However, this role can be remote)*.

Key Responsibilities:

  • Assist in the development of the ongoing global regulatory strategy
  • Submissions of NDAs and amendments
  • Applications and submissions to the FDA as required following post approval obligations and commitments, as well as prepare response to questions raised by FDA
  • Maintain all approvals by submitting annual updates as needed (example Orphan designations, Investigator Brochure)
  • Support Quality and Pharmacovigilance colleagues in systems management
  • Prepare and/or collate all documentation to support clinical trial applications
  • Assist sites in submitting applications to IRBs, and preparing responses to questions raised by IRBs and updated documentation as required
  • Ensure investigation medicinal product is supplied to the study sites in compliance with all regulatory requirements, including packaging
  • Manage packaging material manufacturing and create secondary packaging material
  • Review and approve contract manufacturer's specifications and packaging documents

Qualifications:

  • Minimum 5 years pharmaceutical industry experience
  • Proven experience in preparation of New Drug Applications
  • Proven experience in regulatory management of centrally approved products
  • Understanding of Orphan Drug requirements
  • Proven understanding of eCTD Modules 1-5
  • Preparation of marketing authorization applications in eCTD format
  • Proven experience in labelling, pricing and reimbursement procedures (desirable)
  • Preparation of CTAs to support clinical trials (desirable)


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