REPORTING TO THE REGULATORY AFFAIRS DIRECTORATE, YOUR OVERALL MISSION WILL CONSIST OF:
- Organising, managing and coordinating Regulatory Affairs activities of the products for which you are responsible, ensuring respect of applicable regulations,
- Ensuring maintenance of the validity of existing MAs under your responsibility in line with the company strategy.
- Being the contact for healthcare authorities in the context of the various regulatory procedures.
- Implementing the technical/regulatory strategy on current projects.
- Carrying out regulatory monitoring.
- Implementing the Transparency policy with regard to communication with healthcare professionals.
- Carrying out your functions in full respect of the Charter and Certification Standard for solicitation or market research information activities aiming for the promotion of drugs from March 2017.
YOUR MISSION IS DIVIDED ACROSS FOUR MAJOR FUNCTIONS
1 – Registration and maintenance of product MAs
- Constituting market authorisation dossiers, coordinating and planning the submission of registration dossiers, ensuring coherence between the constituent portions of the dossier (pharmaceutical, preclinical, clinical).
- Monitoring regulatory dossier projects under your responsibility
- Monitoring the assessment of the dossiers by the healthcare authorities and answering the various questions from the authorities throughout the life of the product.
- Managing, in conjunction with our international partners, the scientific support necessary for export registrations of these products.
- Implementing the necessary actions to obtain MAs and rectifications in the shortest timescale possible.
- Manage rectifications, annexes and legal statements as soon as feedback is received from the authorities.
2 – Packaging items control
- Validating the packaging items created or modified in compliance with the MA of the different products and applicable procedures.
3 – Advertising control
- Carrying out the regulatory monitoring of promotional elements and ANSM follow-up.
4 – National and international regulatory monitoring
- Ensuring the monitoring of regulatory activities on internal databases.
- Participating in department meetings regarding regulatory strategies
- Providing consultancy and assistance on regulatory aspects for other departments.
Pharmacist – at least 5 years experience in a similar environment and post (regulatory affairs).
English : fluent
Position available immediately in CDI, full-time
Work from home 2 days a week.