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Alternance - Chargé(e) Affaires Réglementaires (H/F)

Hybride
il y a 1 semaine
Colombes, Ile-de-France, France
Description du poste

About Biogaran

Biogaran is a pioneering laboratory in generic medicines in France, established in 1996. Today, it covers a wide range of pathologies, from everyday ailments to the most severe conditions. With over 1000 drug references and services promoting adherence, Biogaran plays a significant role in the health of French citizens. In the last 12 months, Biogaran sold 347 million boxes of medicines in France, representing more than 1 in 8 reimbursed medicine boxes in France.

More information on the Biogaran website. Follow us on social networks: , ,

  • Internal data - January 2025
  • GERS Sell-In Métropole data as of: Dec. 24
  • GERS Sell-In Métropole data as of: Dec. 24

Missions

Within Biogaran's Registration - Regulatory Affairs Department, you will support your supervisor in the daily activities of the department:

  • Carrying out pharmaceutical variations impacting the active ingredient and/or the finished product for submission to health authorities and monitoring their approval.
  • Carrying out clinical variations for submission to health authorities, monitoring their approval and implementation, as well as validating packaging components.

Additionally, your missions will include: Supporting the business referent(s) of the department based on regulatory updates (safety and/or CMC), for example: ADC/Pregnancy pictograms, monitoring API additions, etc.

Candidate Profile

You are a student in your 5th or 6th year of pharmacy or in the final year of chemical/biological engineering studies and wish to undertake this apprenticeship. You are rigorous, adaptable, and curious, enjoy teamwork, and possess analytical and synthesis skills. Proficiency in English and the Microsoft Office suite (Word, Excel, Outlook).

Why Join Biogaran?

Biogaran is a dynamic, human-sized company where our employees make the difference. Our ambition, in line with our values, is for you to experience a long-term relationship built on trust, encouraging you to express your qualities and develop your skills.

"Dare to innovate, Care, Develop through sharing, and Commit to succeed" are the values that guide our actions. Biogaran is committed to diversity by promoting pluralism in our recruitment processes. Hybrid work is possible (alternating on-site presence and remote work).

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