02 Sep
Senior Manager Reg CMC Lead
Massachusetts, Cambridge , 02138 Cambridge USA

Vacancy expired!

Candidates must be sitting in the US on a W2 Real Staffing Group is combing the Life Science Market for a Senior Manager, Regulatory CMC Lead for oligonucleotide (small molecule) development programs with EU submission expected. Specifically, regulatory CMC professional with small molecule development experience. Experienced in preparing submissions IND/IMPDs for Phase 1, 2 and 3 programs and late-stage program support for NDA or MAA) and oversight of development team working on the Asset team.

Responsibilities:
  • Regulatory Affairs, Small molecule CMC experience - specifically global CMC focus on IND, IMPD and CTA submissions and Agency response to questions.

  • Ideally experience with coordinating or contributing to global filing CTD content within M3.
  • Regulatory experience with global regulatory strategy, operations and planning for the CMC aspects of assigned projects/products.

  • Pulling documentation to support M1 requirements for region

Qualifications
  • Experienced in technical/regulatory writing.
  • Successful authoring and contribution to delivering CMC submission documents of development.

  • Good communication skills and experience working cross-functionally and globally.
  • Quick learner and able to navigate electronic systems to find information and apply to the given program.
  • Ability to work, with responsibility, both independently and within project teams or committees to attain group goals and key project milestones

Location: Cambridge MA based - Can be 100% remote for an ideal candidate.

Benefits:
  • Health insurance

  • Casual Dress code
  • 401k match

  • Employee Perk program

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EOE Statement: Specialist Staffing Group is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.

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