Regulatory Affairs Director
| Verified Pay check_circle | Provided by the employer$230000 - $280000 per year |
|---|---|
| Hours | Full-time |
| Location | Watertown, Massachusetts |
About this job
Job Description
Seeking an experienced Regulatory CMC professional to lead Chemistry, Manufacturing, and Controls (CMC) regulatory strategy across multiple development programs. This role will partner with cross-functional teams to develop global regulatory strategies, support submissions, and ensure compliance throughout product development and commercialization.
Key ResponsibilitiesLead the preparation and review of CMC sections for global regulatory submissions, including INDs, IMPDs, BLAs, and responses to Health Authority inquiries.
Provide regulatory authoring support for manufacturing and quality teams, including documentation for clinical and commercial manufacturing changes.
Develop and execute CMC regulatory strategies while proactively identifying and mitigating regulatory risks.
Serve as the Regulatory CMC representative on cross-functional project teams and provide regulatory guidance throughout product development.
Partner with Technical Operations and Quality teams to ensure global regulatory requirements are incorporated into development activities.
Support the execution of regulatory policies, processes, and high-quality submission deliverables.
Communicate regulatory strategies, risks, timelines, and mitigation plans to project teams and senior leadership.
Bachelor's degree in Life Sciences or a related scientific discipline.
8+ years of Regulatory Affairs CMC experience within clinical-stage and/or commercial biotechnology or pharmaceutical organizations.
Experience supporting biologics; experience with antibody-drug conjugates (ADCs), antibodies, protein conjugates, or rare disease programs is highly preferred.
Strong knowledge of FDA regulations, EU regulatory requirements, ICH guidelines, eCTD submissions, and global CMC regulatory expectations.
Thorough understanding of the drug development lifecycle, global regulatory pathways, and evolving regulatory policies.
Proven ability to manage multiple projects independently in a fast-paced environment.
Strong collaboration skills with cross-functional teams, including Manufacturing, Technical Operations, and Quality.
Excellent regulatory writing, verbal, and written communication skills with strong attention to detail.
Demonstrated leadership, sound judgment, and the ability to effectively communicate regulatory strategy and risks to senior management.
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