Regulatory Affairs Pharmacist

We are seeking a highly skilled Regulatory Affairs Pharmacist to join our team at Bioprojet.

This is a full-time position available immediately, with the opportunity to work from home 2 days a week. As a Regulatory Affairs Pharmacist, you will be responsible for ensuring the compliance of our products with European regulations.

Your primary mission will consist of organizing and managing Regulatory Affairs activities, maintaining the validity of existing Marketing Authorizations (MAs), and being the contact for healthcare authorities.

You will implement the technical/regulatory strategy on current projects, carry out regulatory monitoring, and ensure the maintenance of MAs in line with company strategy.

• Constituting market authorisation dossiers and coordinating their submission to health authorities.
• Monitoring regulatory dossier projects and assessing feedback from authorities.
• Managing scientific support for export registrations and implementing necessary actions to obtain MAs.
• Validating packaging items and carrying out regulatory monitoring of promotional elements.
• Ensuring national and international regulatory monitoring and providing consultancy on regulatory aspects.

To be successful in this role, you should have at least 5 years of experience in a similar environment and hold a PharmD degree. You should also be fluent in English and have excellent communication skills.

This role offers an attractive salary of approximately €85,000 per year, based on industry standards and location. In addition, you will have the opportunity to work with a dynamic team and contribute to the growth of our company.

Bioprojet is a leading biopharmaceutical company dedicated to developing innovative treatments for various diseases. We offer a stimulating work environment, professional development opportunities, and a competitive compensation package.