The Regulatory Affairs Manager will act as an internal Regulatory contact for Pharmacovigilance, Marketing and Business. Also, he or she will be responsible for maintaining policy and regulatory intelligence. He or she will be in charge of providing strategies for projects as Regulatory Affairs representative in cross-functional teams.
The main responsibilities for this role are:
- The maintenance of EMEA registration files
- The maintenance of API DMF
- The preparation of registration files for new territories in EMEA countries
- The coordination with partners, regional regulatory teams for global strategy
- The design and development of regulatory strategies for assigned territories
- The maintenance and update of the Product Information
- The preparation and review of regulatory submissions
Minimum experience requirements:
- At least 5 years’ experience in Pharmaceutical Regulatory Affairs for sterile parenteral chemical drugs, ideally prolonged-release formulation
- Experience in preparation and maintenance for DMF for chemical API
- Experience with Chinese Authorities and previous experience in meeting with Health agencies
- Excellent communication skills in both French and English.