Regulatory Affairs Specialist
il y a 2 semaines
As a key member of the Regulatory Affairs Directorate at Bioprojet, your primary mission will be to ensure the compliance of our products with applicable regulations.
Key Responsibilities:
- Organize, manage, and coordinate Regulatory Affairs activities for assigned products, ensuring respect of applicable regulations.
- Maintain the validity of existing Marketing Authorizations (MAs) under your responsibility, aligning with the company's strategic objectives.
- Act as the primary contact for healthcare authorities during regulatory procedures.
- Implement the technical and regulatory strategy for current projects.
- Conduct regulatory monitoring and ensure compliance with Transparency policies.
- Perform your duties in accordance with the Charter and Certification Standard for solicitation or market research information activities aiming for the promotion of drugs.
Key Functions:
1 – Registration and Maintenance of Product MAs- Prepare market authorization dossiers, coordinate and plan the submission of registration dossiers, ensuring coherence between the constituent parts of the dossier.
- Monitor regulatory dossier projects under your responsibility.
- Track the assessment of dossiers by healthcare authorities and respond to questions from authorities throughout the product's lifecycle.
- Manage, in collaboration with international partners, the scientific support necessary for export registrations of these products.
- Implement actions to obtain MAs and rectifications in the shortest possible timeframe.
- Manage rectifications, annexes, and legal statements upon receipt of feedback from authorities.
- Validate packaging items created or modified in compliance with the MA of different products and applicable procedures.
- Conduct regulatory monitoring of promotional elements and ANSM follow-up.
- Ensure the monitoring of regulatory activities on internal databases.
- Participate in department meetings regarding regulatory strategies.
- Provide consultancy and assistance on regulatory aspects for other departments.
Requirements:
Pharmacist – at least 5 years of experience in a similar environment and role (regulatory affairs).
English: fluent
Position available immediately in CDI, full-time
Work from home 2 days a week.
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