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Manager/Senior Manager, Regulatory CMC

Reference Number: 2802
Location: MA

Our client is a biopharmaceutical company focused on the development and commercialization of products for unmet medical needs.  They have asked us to assist them in their search for a Manager/Senior Manager, Regulatory CMC.

The Manager/Senior Manager, Regulatory CMC is responsible for regulatory execution activities associated with investigational and marketed products with a focus on CMC areas.  The role involves coordinating, writing, and reviewing CMC documents for regulatory submission purposes, conducting regulatory research and summarizing information for the team, and helping to share, rapidly disseminate and track regulatory information.

Major tasks and responsibilities will include:

  • Coordinates the preparation and filing of CMC sections of submissions with input from the technical team.
  • Acts as a contributing author for regulatory submission documents.
  • Reviews CMC documents and provides regulatory guidance to project teams.
  • Reviews prior regulatory advice in the context of clinical, preclinical and CMC submission documents.
  • Works with Regulatory Operations to ensure e-submissions are complete and technically compliant in accordance with eCTD specifications.
  • Interacts with global partners.
  • Aligns with pharmacovigilance for CMC aspects of safety reviews and core data maintenance.
  • Establishes or reengineers SOPs or department guidelines, as needed.
  • Reviews change control requests, deviations, investigations and product complaints.

We seek candidates with the following qualifications:

  • MS or above is required.  PhD in scientific discipline preferred.
  • At least 6 years of direct, progressively responsible, pharmaceutical experience, of which at least 4 years must involve regulatory projects focusing on CMC with biotechnology products.
  • Demonstrated project management and organizational skills.
  • eCTD experience required.
  • Solid understanding of global business cultures preferred.
  • Excellent verbal and written skills.
  • Team player with encouraging attitude.
  • Embraces challenge and innovation.
  • Proactively shares and communicates.
  • Excellent cross-functional team member.
  • A well organized, self-motivated and independent work style with the ability to initiate and follow through on assignments.

 

Do you have the skills and experience we seek and want to advance your career with one of the world’s leading companies? If so, please email your resume as a Word attachment to us, reference 2802. No calls or faxes, please. Include your daytime phone number and we will contact you confidentially or reply to your email.