Senior Regulatory Affairs manager – CMC

Cambridge - USA

Monthly Salary: Not Disclosed

Posted on: 30+ days ago

Vacancies: 1 Vacancy

Job Summary

Responsibilities:

Author and compile CMC sections of regulatory applications including INDs IMPDs CTAs amendments and annual reports.
Documentation: Draft and maintain high-quality CMC regulatory documents such as Module 2 and 3 summaries stability reports and comparability protocols.
Communication: Support regulatory interactions by preparing responses to CMC-related questions from FDA EMA PMDA and other global health authorities.
Strategy Implementation: Execute CMC regulatory strategies as defined by regulatory leadership to support clinical trial initiation and advancement.
Cross-functional Collaboration: Partner with Technical Operations Quality Manufacturing and external vendors to gather verify and compile CMC information.
Process Development: Contribute to the development of templates processes and workflows to support efficient and compliant CMC regulatory operations.
Other duties as assigned.

Requirements:

Bachelors degree with a minimum of 5 years of experience in CMC regulatory affairs including experience with clinical biologics programs or equivalent related experience.
Hands-on experience authoring and compiling CMC sections of INDs IMPDs CTAs amendments and related filings.
Strong knowledge of global CMC clinical regulatory requirements and guidelines including FDA EMA and ICH.
Experience with biologics drug-device combination products (e.g. pre-filled syringes auto-injectors) or diagnostics (companion diagnostics) preferred.
Excellent attention to detail technical writing organizational and communication skills.
Ability to manage multiple deliverables and timelines in a fast-paced environment.
Proficiency with regulatory document management systems.

Responsibilities: Author and compile CMC sections of regulatory applications including INDs IMPDs CTAs amendments and annual reports. Documentation: Draft and maintain high-quality CMC regulatory documents such as Module 2 and 3 summaries stability reports and comparability protocols. Communication...