- 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.
- 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.
- Validating the packaging items created or modified in compliance with the MA of the different products and applicable procedures.
- Carrying out the regulatory monitoring of promotional elements and ANSM follow-up.
- 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.
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Regulatory Affairs Pharmacist – France and international - Bezons, France - Bioprojet
il y a 2 semaines
Description
REPORTING TO THE REGULATORY AFFAIRS DIRECTORATE, YOUR OVERALL MISSION WILL CONSIST OF:
YOUR MISSION IS DIVIDED ACROSS FOUR MAJOR FUNCTIONS
1 – Registration and maintenance of product MAs
2 – Packaging items control
3 – Advertising control
4 – National and international regulatory monitoring
PROFILE
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.
