Senior pharmacist with 13 years of combined experience in international Regulatory Affairs and Quality Assurance.
Services either on-site in the area of Lyon or from remote office:
_ guidance, strategy and hands-on support at every stage of product's lifecycle
_ compliance with regulatory and QA requirements
_ flexible and transparent service, tailored to the needs of the client
Regulatory Affairs
- Writing of CMC, Quality parts (Modules 2.3 & 3)
- Audits of MA dossiers and ASMF
- Industrial sites transfers management for API, DP
- Preparation, submission of Marketing Authorization dossiers
- Regulatory liaison, strategic advice, meetings, negotiation with Health Authorities
- Labelling
- Validation of promotional documents
Quality Assurance and Qualified Person responsibility
Registered as QP “Exploitant” on the register of the French Chamber of Pharmacists
- Writing of SOP and departmental processes
- Update of QA documentation for MA holder or French “Exploitant” site
- Preparation for Health Authority inspection
- Qualification and management of manufacturers, distributors
Pharmacovigilance
- PV system supervision
- Safety Data Exchange Agreements
- Medical information handling
Mes compétences :
Variations
Industrial transfers
GMP
Pas de formation renseignée
