Senior Manager, Global Regulatory Affairs - CMC

Role Summary

Senior Manager, Global Regulatory Affairs - CMC responsible for authoring/writing CMC specific regulatory dossiers (3.2.S and 3.2.P) toward the development and commercialization of radiopharmaceutical and biopharmaceutical products. Develop ICH aligned CMC/Technical portions of global regulatory submissions that are high-quality, fit for purpose, and prepared in a timely manner across 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 the use of regulatory domain systems (Veeva) and processes.
• Regulatory Compliance and Intelligence: Stay current and interpret evolving CMC regulatory requirements and guidelines such as ICH, US FDA CFRs, EMA Directives and Annexes. Ensure CMC documentation and data are compliant with regulations.
• Cross-Functional Collaboration: Collaborate with internal stakeholders, including Quality Assurance, CMC/Manufacturing, and preclinical teams for planning and authoring of CMC regulatory scope and content.
• Change Management: Provide regulatory assessments for manufacturing changes, including site transfers, scale-up activities, and process changes. Conduct comparability assessments and develop post-approval supplements as needed.
• Risk Management: Identify potential CMC regulatory risks and suggest mitigation plans to proactively manage issues.

Qualifications

• Undergraduate degree required; Advanced degree (M.Sc., Ph.D.) with a focus in Biological Sciences, Engineering or a related field preferred.
• 9+ years of experience with a strong focus on CMC in the radiopharmaceutical or biopharmaceutical industry.
• Regulatory Knowledge: Solid understanding of global regulatory requirements and guidelines for CMC, including ICH guidelines and FDA, EMA, and other health authority regulations.
• Communication Skills: Excellent technical writing and verbal communication skills, with the ability to effectively communicate complex regulatory issues to internal and external stakeholders.
• Analytical Skills: Good analytical and problem-solving skills, with the ability to assess and mitigate regulatory risks.
• Interpersonal Skills: Ability to work collaboratively and build effective relationships across functions and geographies.
• Technical Writing: Skilled at summarizing pharmaceutical manufacturing and method development reports, data into appropriate sub-sections of Module 3.

Skills

• Regulatory submissions management
• Global CMC regulatory compliance
• Technical writing and communication
• Cross-functional collaboration
• Regulatory risk assessment
• Regulatory intelligence and interpretation of guidelines

Education

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

Additional Requirements

• Experience with radiopharmaceuticals or related modalities