Amandine Gras

Amandine Gras

Senior CMC Consultant

Key Knowledge Areas:

- Pharmaceutical development
- CMC regulatory affairs
- Project Management

Pitch

Amandine has an extensive experience in pharmaceutical development, CMC regulatory affairs and project management gained through 20 years of working within the pharmaceutical industry. In 2018, she got the PMP® certification, the industry-recognized certification for project managers.

 

 

About Amandine

Amandine is a senior CMC regulatory affairs professional specialised in development and advise on RA-CMC strategies, in implementation of RA-CMC requirements in product development, support in scientific advice procedures, communication with health authorities and RA-CMC (Module 3, IMPD) technical writing.

Background/Past experience

Amandine started her professional career at Galderma R&D in analytical development as an analytical team leader. She was in charge of defining the analytical development strategy, leading the development & validation of analytical methods, the establishment of specifications and monitoring stability studies.

 

In 2012 she joined the CMC coordination and expertise group, at Galderma R&D.

 

In her role of CMC product manager, Amandine was responsible for coordinating product development activities, from early stages to industrial transfer and registration.

 

As CMC expert, she defined CMC regulatory strategy related to the development of drug substances and drug products and prepared CMC regulatory documents and answers to questions from Health Authorities. She has supported several pre approval submissions all over the world. Amandine has also a thorough understanding in impurity management and pharmacopeia monograph elaboration.

 

 

 

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