Program Manager - Global Regulatory Affairs CMC (gRA CMC), Hybrid job vacancy

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Job Title: Program Manager - Global Regulatory Affairs CMC (gRA CMC), Hybrid Location: Cambridge / Boston, MA

Duration: 6-12 months

Detail Job Description:

Responsibilities

Lead the development, implementation, and execution of the regulatory CMC strategy for development projects
Ensure all regulatory submissions and CMC projects are aligned with defined regulatory strategy and proactively identify gaps, work with cross-functional teams to develop mitigation proposals
Lead and manage preparation of high-quality regulatory submission content of the CMC sections to support global clinical development and registration
Represent regulatory CMC in global multi-disciplinary meetings/forums that require experienced interpretation of applicable EMA/FDA/ICH/WHO/Global regulations to ensure CMC compliance and achievement of regulatory department and program objectives
Participate in regulatory CMC discussions and interactions with health authorities to facilitate review and approval of submissions
Ensure that program team colleagues, line management, and partners are informed of developments that may affect regulatory success
Manage regulatory compliance activities including periodic regulatory reporting, review of technical documents, and providing regulatory assessments on deviations, CAPAs, change controls, etc.

Requirement

Degree in pharmacy, chemistry, biology, biochemistry, or equivalent
6+ years professional experience in Global Regulatory Affairs CMC during clinical, registration for Biologics, Vaccines and/or Small Molecules
Extensive experience in preparation, revision, and maintenance of regulatory CMC documents for clinical trial approvals (IMPD, IND) and marketing authorizations (BLA, MAA)
Knowledge of CMC drug development (Drug Substance and Drug Product) and knowledge of multidisciplinary functions involved in drug development and manufacturing
Good combination of strategic and operational skills; ability to make flexible, but thorough decisions in a highly dynamic environment

Regards,

Harjeet Singh

Marlabs