Regulatory Affairs Specialist

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.

2 – Packaging Items Control

• Validate packaging items created or modified in compliance with the MA of different products and applicable procedures.

3 – Advertising Control

• Conduct regulatory monitoring of promotional elements and ANSM follow-up.

4 – National and International Regulatory Monitoring

• 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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