Senior Manager/Associate Director, Regulatory Affairs - CMC

Synageva BioPharma

Regulatory

April 22, 2014

JOB TITLE: Senior Manager/Associate Director, Regulatory Affairs -CMC

REPORTING RELATIONSHIP: Director, Regulatory Affairs - CMC

DATE AVAILABLE: Immediately

LOCATION: Lexington, MA

 

RESPONSIBILITIES:

The successful candidate for this role will be responsible for providing global regulatory support across the Synageva disease/product portfolio. This will include contributing to the definition of CMC requirements for IND/CTAs and marketing application approvals, acting as a supportive RA representative on Technical Operations and Analytical teams, preparing responses to CMC questions arising from competent authority reviews, and contributing to the RA-CMC strategy for global submissions and approvals for our products.  His/her specific job responsibilities will include:

  • Leading the preparation of the CMC content for clinical trial applications for a pipeline product and acting as the primary RA-CMC representative for that project team.
  • Supporting dossier preparation for lead product to assure timely and high-quality submission development.
  • Contributing to pre-submission meetings with regulatory authorities to reach agreement on complex CMC requirements for approvals of products.
  • Working with Technical Operations, Quality, Analytical and other relevant departments to assure BLA/CTD readiness from a CMC perspective for lead product
  • Managing, tracking, and assuring Synageva’s accountability to global regulatory CMC commitments.

Providing RA-CMC support and advice for all internal activities related to manufacturing, development, control, and quality of products in development.

QUALIFICATIONS:

Minimum Job Requirements:

  • BA/BS degree in a scientific discipline (advanced degree preferred)
  • Minimum of 7 years of experience in Regulatory CMC within the biotechnology/pharmaceutical industry; experience with protein therapeutics or other biological products preferred
  • Strong written and verbal communication skills
  • Substantial understanding of current state-of-the-art manufacturing, controls, and analytical requirements associated with biologics development and approval
  • Experience managing complex CMC submissions to and responding to questions from global regulatory authorities
  • Excellent interpersonal skills and proven ability to work as part of an effective team
  • Self-motivated and results-oriented with the high energy drive to achieve objectives that support the business

 

Apply Now

  • Company Synageva BioPharma
  • Contact Name Jeff Kagy
  • Position Location Lexington, MA
  • Minimum Required Education Bachelor's Degree
  • Minimum Preferred Education Master's Degree
  • Minimum Years Experience 7
  • Career Level Manager
  • Size of Company in MA 200
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