Remote Opportunity

Responsibilities of the Sr. Manager, Regulatory Affairs (CMC):

• Assist in developing and implementation of robust, global regulatory CMC strategies to meet program objectives across early- and late-stage development.
• Anticipate regulatory risks and emerging issues, proposing mitigation plans and solutions.
• Author and review high-quality CMC sections (Module 3) for INDs, IMPDs, CTAs, NDAs, and MAAs, ensuring compliance with ICH, FDA, EMA, and other global regulatory requirements.
• Summarize technical data (e.g., method validation, batch analysis, stability studies, process descriptions) into concise regulatory documents, ensuring alignment with source documentation.
• Support the review and approval of technical source reports to be used for regulatory submissions, ensuring a first pass review of process documents from a regulatory perspective.

Requirements of the Sr. Manager, Regulatory Affairs (CMC):

• Bachelor’s degree in Life Sciences required; advanced degree (M.Sc. or Ph.D.) preferred.
• A minimum of 8 years of experience in the pharmaceutical or biotechnology industry, with at least 6 years in Regulatory Affairs CMC.
• Hands-on experience with IND, CTA, and NDA/MAA submissions, including Module 3 authoring and lifecycle management.
• Proven track record of working on U.S., EU, and Canada submissions.