MASSY
- 8 years of experience in Regulatory Affairs (North America and Europe)
- Combine science and regulatory affairs background
- Liaise with external regulatory agencies (EMA, EU national agency, Health Canada and FDA)
- Maintain awareness of current and new legislation/guidance and ensure that MA folders are in compliance with the statutory requirements.
- Lend support to cross-functional teams to ensure CMC guidelines are followed in compliance with industry standards
- Manage regulatory assessments on topics including change controls, deviations and GMP
- Ensure systems and procedures (SOP) are up to date
- Manage several projects simultaneously
- Products: ATMP, Immunothérapy, sterile and modified release drug products,
- Excellent verbal and written communication and presentation skills
Mes compétences :
Affaires réglementaires
AMM
Brevet
Droit
EMEA
FDA
Intellectual property
International
Santé