Regulatory CMC (Chemistry, Manufacturing and Control) Associate

Regulatory CMC (Chemistry, Manufacturing and Control) Associate

Sanofi

Waterford, Ireland

About the job

As Regulatory CMC (Chemistry, Manufacturing and Control) Associate VIE within our Chemistry, Manufacturing and Control team, you’ll join a workplace where diversity, equity, and inclusion are at the core, with Employee Resource Groups and leadership programs that celebrate every voice.

Main responsibilities:

• Participate in the definition of regulatory strategies for pharmaceutical changes to our marketed synthetic drug portfolio and for new registrations, ensuring that risks are identified, communicated and controlled.
• Contribute to the analysis of global regulatory requirements.
• Take part, in collaboration with the Industrial Affairs and Regulatory Operations functions, in the preparation, review and approval of files according to quality standards before submission to the Authorities.
• Participate in the coordination and definition of the strategy for responding to the questions received from the Authorities.

About you

Experience:

• Previous experience in the pharmaceutical industry related to the position.

Education:

• Master’s Degree in Chemistry/Pharmacy or Engineering School (specialization in Regulatory Affairs is a plus).

Soft and technical skills:

• Curios, rigor, proactive, team-player.
• Pharmaceutical industry knowledge (Regulatory, Quality, etc.).

Languages:

• Fluent in English.