Regulatory Affairs specialist – Temporary – 4 months contract

Job Description

Ensure the application of pharmaceutical regulations relating to the exploitation of health products and the information charter by canvassing or prospecting aimed at the promotion of medicines.

What you will do

• Validation and implementation of the French versions of the texts of the marketing authorizations of our products as well as the mandatory information
• Validation of the packaging items of the products in charge in collaboration with the Quality team
• Ensure the validation of training materials for sales force in accordance with the regulations

• Ensure regulatory compliance of advertising and promotional information

• Be the referent in the department to answer the related Business Unit teams’ questions

• Collaboration with international departments (Quality, Regulatory Affairs, Logistics).

Qualifications

Pharmacist with 2-3 years’ experience

Idealy additionally Master II of Health Law

Competencies

• Knowledge of pharmaceutical regulations.
• Knowledgeof centralised registration procedures
• Knowledge of office automation (Power Point, Word, Excel, Database).
• Fluency in English

Additional Information

Why Biogen?

Our mission to find therapies for neurological and rare diseases is a unique focus within our industry and this shared purpose is what connects us as a team. We work together to overcome obstacles and to follow the science. We are resilient as we strive to make an impact on our patients’ lives and on changing the course of medicine. Together, we pioneer. Together, we thrive.

At Biogen, we are committed to building on our culture of inclusion and belonging that reflects the communities where we operate and the patients we serve. We know that diverse backgrounds, cultures, and perspectives make us a stronger and more innovative company, and we are focused on building teams where every employee feels empowered and inspired. Read on to learn more about our DE&I efforts

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