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Manager/Senior Manager, CMC Regulatory Affairs

Reference Number: 4028
Location: NY

Our client is a clinical stage biopharmaceutical company developing novel recombinant viral vector vaccines against cancer and infectious diseases. We have been asked to identify candidates for their Manager/Senior Manager, CMC Regulatory Affairs.

Major tasks and responsibilities will include: 

  • Serves as Head of US CMC Regulatory Affairs, responsible for key regulatory activities in support of the development and commercialization of company products.
  • Develops and implements regulatory strategies for the earliest possible product approval.
  • Drives adherence to US and EU regulatory CMC and GMO requirements and guidelines for development of company products.
  • Coordinates and responds, as necessary, to requests for information regarding Genetically Modified Organisms (GMO) from Regulatory Authorities.
  • Authors and/or reviews regulatory documentation for submissions and documentation.
  • Assists with preparations for FDA meetings.
  • Provides regulatory review and approval of cGMP documentation.
  • Represents regulatory concerns on interdisciplinary project teams.
  • Participates in regulatory intelligence activities.
  • Monitors regulatory guidelines and trends.
  • Leads knowledge of current industry-related topics, in particular GMO testing events and requirements.
  • Ensures CMC and GMO issues impacting global regulatory strategy for proposed regulatory filings are taken under consideration.
  • Manages regulatory submissions that involve CMC components.
  • Drives follow-up action plans resulting from agency feedback.
  • Participates in negotiations with regulatory agencies.
  • Assists during regulatory agency inspections.
  • Actively participates in Regulatory Affairs infrastructure and capability building.
  • Provides company representation at regulatory and industry organizations involved in setting standards for GMO therapies.
  • Travels on company business, approximately 1 week per 2-4 months.

We seek candidates with the following qualifications:

  • Bachelor’s degree in life science related field required. Advanced degree (MS or PhD) highly preferred.
  • Must have a minimum 6+ years of experience in the pharmaceutical or biotech industries.
  • Must have a minimum of 4+ years regulatory affairs experience, including regulatory CMC and/or GMO strategy for development and/or commercial pharmaceutical products.
  • Experience with immuno-oncology products, ATMPs, cell and gene therapy, and/or vaccines highly preferred.
  • Requires experience working in a global, matrix environment.
  • Must have solid understanding of the line functions and their role in research and development.
  • Strong interpersonal skills required.
  • Requires excellent communication skills, both written and oral, and exceptional attention to detail.
  • Must have demonstrated organizational skills, including the ability to prioritize tasks and adhere to agreed timelines.
  • Understanding of electronic submissions required.
  • Requires knowledge and understanding of US, EU, Canada, and ICH guidelines.
  • Understanding of international GMO requirements highly preferred.
  • Must be highly computer literate.

If interested, please email your resume as a Word attachment to us, reference 4028.  No calls please. Include your daytime phone number and we will contact you confidentially or reply to your email.

Fairway Consulting Group is included in Hunt Scanlon’s list of Top 50 Healthcare & Life Sciences Search Firms.