Manager, Global Regulatory Affairs – CMC

This is a fully remote position, open to applicants in United States.

📋 Description

• Composing and developing CMC-specific regulatory documents (sections 3.2.S and 3.2.P)

• Organizing and refining eCTD Module 2.3 & Module 3 documentation for INDs, IMPDQs, NDAs, BLAs, MAAs, CTAs, as well as post-approval supplements and variation submissions

• Ensuring that Module 3 documentation is methodically planned, monitored, and clearly articulated

• Keeping abreast of and interpreting the evolving CMC regulatory requirements and guidelines

• Collaborating with internal stakeholders, including Quality Assurance, CMC/Manufacturing, and preclinical teams

• Providing regulatory evaluations for changes in manufacturing

• Identifying potential CMC regulatory risks and proposing mitigation strategies

⛳️ Requirements

• A bachelor's degree is mandatory; an advanced degree (M.Sc., Ph.D.) in Biological Sciences, Engineering, or a related discipline is preferred.

• Over 7 years of experience with a strong emphasis on CMC within the radiopharmaceutical or biopharmaceutical sectors.

• Comprehensive knowledge of global regulatory requirements and guidelines for CMC, including ICH guidelines and FDA, EMA, and other health authority regulations.

• Exceptional technical writing and verbal communication abilities.

• Strong analytical and problem-solving capabilities.

• Proven ability to collaborate effectively and build strong relationships across various functions and locations.

• Proficient in summarizing reports related to pharmaceutical manufacturing and method development.

🏝️ Benefits

• Competitive salaries

• Annual performance-based bonuses

• Equity-based incentive program

• Generous vacation

• Paid wellness days

• Support for learning and development