Senior Director, Regulatory Affairs, CMC
New
J
JobgetherBiotechnology, oncology
Full-time remote opportunity based in the United States.Full-TimeDirector
SalaryAnnual compensation ranging from $204,500 to $274,500
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Job Details
- Experience
- At least 12 years of relevant pharmaceutical or biotechnology industry experience, including substantial experience in Regulatory CMC.
- Required Skills
- People Management
Requirements
- Bachelor’s degree in a scientific discipline required; a master’s degree or PhD is preferred.
- At least 12 years of relevant pharmaceutical or biotechnology industry experience, including substantial Regulatory CMC experience.
- Demonstrated experience leading one or more antibody-drug conjugate programs through development milestones.
- Experience ideally includes IND submission through BLA or MAA and health authority interactions.
- Experience establishing and executing global CMC regulatory strategies and coordinating regional regulatory activities.
- Strong experience with CMC dossier preparation, regulatory submission management, agency interactions, and product lifecycle maintenance.
- In-depth understanding of CMC development, manufacturing processes, product quality, regulatory change control, and applicable pharmaceutical regulations and guidelines.
- Demonstrated ability to assess regulatory risks, develop mitigation strategies, maintain compliance, and ensure inspection readiness.
- Experience leading, coaching, and developing technical professionals.
- Ability to lead global, cross-functional project teams and influence stakeholders across scientific, technical, operational, and regulatory functions.
Responsibilities
- Lead global CMC regulatory strategy for the ADC portfolio throughout development, registration, commercialization, and lifecycle management.
- Serve as Global Regulatory Lead for a late-stage ADC program approaching BLA submission, coordinating regional regulatory team members.
- Lead preparation, review, finalization, and maintenance of CMC regulatory dossiers and responses.
- Lead health authority engagement and responses to questions.
- Lead and mentor a U.S.-based Regulatory CMC team of approximately five professionals.
- Coordinate with CMC, Manufacturing, Quality, Supply Chain, Clinical, and Global Regulatory Affairs teams.
- Oversee CMC change-control impact assessments and determine regulatory pathways, filing requirements, and timelines.
- Assess regulatory risks, develop mitigation plans, and escalate significant issues to senior leadership.
- Guide regulatory assessments for product quality issues, deviations, complaints, recalls, and lifecycle matters.
- Oversee Regulatory CMC due diligence for licensing, acquisitions, and other strategic opportunities.
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