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Regulatory Affairs Associate Director CMC - San Diego, USA

Regulatory Affairs Associate Director CMC - San Diego, USA

  • Location

    San Diego, California

  • Sector:

    Regulatory Affairs

  • Job type:

    Permanent

  • Salary:

    Negotiable

  • Contact:

    Matt Thomas

  • Contact email:

    matt.thomas@pharma-partners.co.uk

  • Job ref:

    27039_1642691529

  • Published:

    4 months ago

  • Expiry date:

    2022-02-19

  • Consultant:

    #

Job title: Regulatory Affairs Associate Director Chemistry, Manufacturing and Controls (CMC) - San Diego, USA

A small Biopharmaceutical business focused on developing novel pharmaceuticals for the prevention and treatment of infectious diseases are seeking an Associate Director CMC. You will have the opportunity to work in the Company's new state-of-the-art San Diego facility or work remotely within the United States.

Responsibilities:

  • Ensures that all CMC regulatory goals are met and are in compliance with current industry standards and global regulations and are effectively networked with government funding stakeholders
  • Serves as the global steward of CMC Regulatory Affairs processes, procedures, and tools to facilitate effective execution of the regulatory function across the CMC organization
  • Participates in the development of regulatory strategies for the company as well as for product development teams
  • Drafts regulatory submissions pertaining to CMC development and assists technical team members in compilation of relevant material to support overall product development strategies

Requirements:

  • BS or BA Degree in Biology, Chemistry, Pharmacy, Regulatory Affairs for Biologics, or another life-science related field - Advanced degree is preferred
  • 10 years experience in the biotech industry or in a related field, or the equivalent combination of education and experience, with prior experience in a technical role in the CMC function
  • Monoclonal antibodies or protein therapeutic IND and/or BLA filing experience
  • Experience with the FDA in regards to responding to CMC queries and/or requests

Salary and benefits:

The Company offers a competitive compensation and benefits package in addition to this exciting and challenging job

To apply for this position or hear further details then please contact Matt Thomas via matt.thomas@pharma-partners.co.uk