GRA CMC Lead

Main Responsibilities
- Develop and implement global regulatory CMC strategies for both development and marketed small molecule products, adapting to evolving regulatory and business needs.
- Act as direct liaison with agencies such as the US FDA and EMA; support strategic negotiations worldwide.
- Prepare, review, and approve regulatory CMC dossiers, ensuring quality standards and compliance throughout the product lifecycle.
- Lead cross-functional collaboration with R&D, Manufacturing & Supply, and Regulatory Operations; ensure effective strategy implementation and timely resolution of CMC issues.
- Identify and manage regulatory risks by assessing CMC opportunities, developing mitigation strategies, and communicating risk/benefit implications to stakeholders.
- Contribute to regulatory science and policy by participating in reviews of new regulations and anticipating regulatory landscape changes.

About You
Qualifications
- Bachelor’s degree in a scientific discipline (required); Master’s or PhD in a science/health-related/regulatory field (preferred).
- At least 4 years of pharmaceutical industry experience with strong CMC regulatory experience in small molecules, including preparing/managing regulatory filings and responding to Health Authority questions.

Skills
- Excellent communication (concise, informative, persuasive).
- Strong organizational abilities.
- Experience in matrix environments.
- Ability to thrive in fast-paced settings across multiple product lines.
- Foundational understanding of Artificial Intelligence and its impact on industry.

Languages
- Fluency in English (required).