Regulatory Affairs Pharmacist – International and French Markets

il y a 3 semaines


Bezons, Île-de-France Bioprojet Temps plein

REPORTING TO THE REGULATORY AFFAIRS DIRECTORATE, THE PRIMARY OBJECTIVE IS TO ENSURE COMPLIANCE WITH APPLICABLE REGULATIONS AND ENSURE THE VALIDITY OF EXISTING MARKETING AUTHORIZATIONS.

The Regulatory Affairs Pharmacist will be responsible for:

  1. Organizing, managing, and coordinating regulatory activities for products under their responsibility, ensuring compliance with applicable regulations.
  2. Maintaining the validity of existing MAs in line with the company strategy.
  3. Acting as the primary contact for healthcare authorities during regulatory procedures.
  4. Implementing the technical/regulatory strategy for current projects.
  5. Carrying out regulatory monitoring and implementing the Transparency policy with regard to communication with healthcare professionals.
  6. Performing their duties in accordance with the Charter and Certification Standard for solicitation or market research information activities aiming for the promotion of drugs.

THE ROLE IS DIVIDED INTO FOUR MAIN FUNCTIONS:

1 – Registration and Maintenance of Product MAs

Responsibilities include:

  1. Preparing and submitting marketing authorization dossiers, ensuring coherence between constituent parts.
  2. Monitoring regulatory dossier projects under their responsibility.
  3. Tracking the assessment of dossiers by healthcare authorities and responding to queries throughout the product lifecycle.
  4. Managing scientific support for export registrations in conjunction with international partners.
  5. Implementing actions to obtain MAs and rectifications in the shortest possible timeframe.
  6. Managing rectifications, annexes, and legal statements upon receipt of feedback from authorities.
2 – Packaging Item Control

Responsibilities include:

  1. Validating packaging items created or modified in compliance with marketing authorization and applicable procedures.
3 – Advertising Control

Responsibilities include:

  1. Regulatory monitoring of promotional elements and ANSM follow-up.
4 – National and International Regulatory Monitoring

Responsibilities include:

  1. Monitoring regulatory activities on internal databases.
  2. Participating in department meetings regarding regulatory strategies.
  3. Providing consultancy and assistance on regulatory aspects for other departments.

REQUIREMENTS:

Pharmacist with at least 5 years of experience in a similar environment and role (regulatory affairs).
Fluent English.
Full-time position available immediately.
Work from home 2 days a week.


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