Regulatory Affairs Assistant (M/F)
Job Description
Company:  EG Labo - Laboratoires Eurogenerics SAS
Department:  RESEARCH & DEVELOPMENT
Job Location (Long): 

Issy-les-Moulineaux|France

Country/Region:  France
Job Level:  Professionals

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Information at a Glance

Caring for People’s Health

For over 130 years, the STADA Group has been committed to caring for everyone’s health as a trusted partner worldwide. Originally founded by pharmacists, the group is now present in over 120 countries. The dedication and engagement of our 11,600 employees worldwide is our strength. Together, as “One STADA”, we achieve ambitious goals and successfully shape the future of the STADA Group and its subsidiaries.

EG LABO – STADA Group

EG LABO, the French subsidiary of STADA Group, is a key player in generic medicines with a portfolio of over 820 products, as well as OTC with well-known family health brands (Synthol®, Duofilm®, Mitosyl®, …). We are also active in biosimilars, serving both pharmacies and hospitals. Guided by our values and driven by results, our employees make all the difference. To support our growth strategy, we are looking for dynamic and passionate people to thrive alongside us in a professional environment that promotes learning, skill development, and personal growth.


Regulatory Affairs Assistant (M/F)   

Issy Les Moulineaux | France (FR) | Full-time | Permanent 

 

About the position:
Reporting to the Director of Regulatory Affairs and Interim Head Pharmacist, you will join a team of 10 employees. You will play a central role in providing administrative and operational support to the regulatory division.

Main activities:
Proactive interface for internal and external regulatory requests (answering questions, transmitting current legislation, sending regulatory documents).
Regular interface with the Pharmacovigilance Department for regulatory requests (STADA product tables, DMI planning).
Back-up for the Regulatory Affairs Assistant already in post.

Responsibilities: 
•    Administrative management of the LEA/transparency: transparency declarations, CNOP, CNOM, etc.
•    Monitoring of import authorisations for psychotropic substances and narcotics 
•    Distribution of national approvals for variations/renewals/marketing authorisations and letters from the ANSM
•    Management of MA amendments (receipt, filing)
•    Updating of annexes in accordance with MA amendments approved by the ANSM
•    Updating of internal regulatory monitoring tables (monitoring of submissions/MA portfolio, etc.)
•    Filing of Ueurop emails for the products concerned
•    Export: preparation, dispatch and monitoring of CPPs, assistance with registration/renewal applications
•    Various translation requests
•    Daily monitoring and processing of Official Journals
•    Regulatory management of the internal WiredContact database
•    Departmental secretarial duties (meeting minutes, filing, etc.)

 

Your profile:
🎓 Education & Experience:
•    Training in assistant roles (e.g. BTS Executive/Management Assistant or equivalent).
•    Minimum 2 years' experience in a similar role.
•    Experience in a pharmaceutical laboratory is an advantage.
🌍 Language & Office Skills: 
•    French: impeccable spelling, excellent writing skills. 
•    English: good written skills required, professional spoken skills. 
•    Proficiency in Microsoft Office.

🧠 Personal qualities: 
•    Rigorous, curious, proactive and autonomous. 
•    Team player, good interpersonal skills, adaptable, responsive.
•    Ability to manage several tasks simultaneously and autonomously.

 

Why join us? 
At EG LABO, you will work in a supportive, dynamic and stimulating environment, within a growing group that promotes meaningful work and strong values. You will participate in varied and structuring projects, while developing your skills in an enriching professional setting.


What we offer:
Professional immersion: Join a rapidly expanding, people-oriented company that is part of an international group. Learn and develop on a daily basis.
Positive impact: Help improve patients' lives through our segments: OTC, Biosimilars and Generics.
Friendly atmosphere: Work in modern premises in Issy-les-Moulineaux, with regular internal events to strengthen bonds between employees.
Well-being: Enjoy unlimited access to our ‘Health & Well-being’ programme for you and your family, as well as conversation classes and an e-learning platform to improve your foreign language skills.
Top Employers certification: Join a company recognised for its excellent HR practices and commitment to its employees.
Amenities: Enjoy a shared dining area for your lunches and a 75% subsidy on your travel pass.

 



Are you looking for a new challenge where you can contribute to caring for everyone’s health? Submit your application via our portal: jobs.stada.com