EU Pharmaceutical Regulatory Affairs Support

We are looking for an experienced freelance Regulatory Affairs Specialist to support our company with the registration of medicinal products in European countries.

The specialist will be expected to assist with the full registration process, including but not limited to:

Preparation and review of registration dossiers

Submission procedures for medicinal products

Communication with regulatory authorities

Support with variations, renewals, and lifecycle maintenance

Compliance with EU regulatory requirements and guidelines

Coordination of documentation and responses to authority questions

Assistance with local regulatory procedures in different European markets

Requirements:

Proven experience in medicinal product registration in Europe

Strong knowledge of EU pharmaceutical regulatory procedures

Experience with CTD/eCTD documentation

Ability to work independently and meet deadlines

Excellent communication skills in English

Experience with multiple European markets and different registration pathways will be considered an advantage.

Please share your experience, countries/markets you are working with and prices for you services.