Manager, Global Regulatory Affairs - CMC

Role Summary

Manager, Global Regulatory Affairs - CMC responsible for authoring CMC regulatory dossiers (3.2.S and 3.2.P) for radiopharmaceutical and biopharmaceutical products, developing ICH-aligned CMC/Technical portions of global regulatory submissions, and collaborating across functions to ensure timely, high-quality submissions for early-to-late stage and post-approval programs.

Responsibilities

• Regulatory Submissions: Plan, prepare/revise eCTD Module 2.3 & Module 3 documents for INDs, IMPDQs, NDAs, BLAs, MAAs, CTAs, post-approval supplements, and variation submissions, ensuring accuracy and completeness.
• Documentation and Systems: Ensure Module 3 documentation is planned, tracked, clearly written, with regulatory domain systems (Veeva) and processes.
• Regulatory Compliance and Intelligence: Stay current with evolving CMC regulatory requirements and guidelines (ICH, FDA CFRs, EMA Directives/Annexes); ensure CMC documentation and data are compliant.
• Cross-Functional Collaboration: Collaborate with Quality Assurance, CMC/Manufacturing, and preclinical teams for planning and authoring CMC regulatory scope and content.
• Change Management: Provide regulatory assessments for manufacturing changes, site transfers, scale-up, and process changes; conduct comparability assessments and develop post-approval supplements as needed.
• Risk Management: Identify CMC regulatory risks and propose mitigation plans.

Qualifications

• Undergraduate degree required; Advanced degree (M.Sc., Ph.D.) in Biological Sciences, Engineering, or related field preferred.
• 7+ years of experience with a strong focus on CMC in the radiopharmaceutical or biopharmaceutical industry.
• Regulatory Knowledge: Solid understanding of global CMC regulatory requirements and guidelines (ICH, FDA, EMA, other health authorities).
• Communication Skills: Excellent technical writing and verbal communication; ability to convey complex regulatory issues to stakeholders.
• Analytical Skills: Strong analytical and problem-solving abilities to assess/regulate regulatory risks.
• Interpersonal Skills: Ability to collaborate across functions and geographies.
• Technical Writing: Able to summarize pharmaceutical manufacturing and method development data into Module 3 subsections.

Skills

• Technical Writing
• Regulatory Submissions
• Cross-Functional Collaboration
• Regulatory Compliance
• Change Management
• Risk Assessment

Education

• Undergraduate degree required; advanced degree preferred (M.Sc., Ph.D.)

Additional Requirements

• No explicit travel or physical demands described as essential in the source.