Regulatory Affairs Specialist - 091

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Regulatory Affairs Specialist - 091, France

Client: ProductLife Group

Location:

Job Category: Other

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EU work permit required: Yes

Job Reference: 3a6f9b12ea13

Job Views: 3

Posted: 24.04.2025

Expiry Date: 08.06.2025

Job Description:

About the job

In the context of our growing activities, we are looking for a Regulatory Affairs Specialist to join our teams in France. You will integrate a team of Regulatory Affairs professionals dedicated to the Multi-clients group and will have the mission to realize activities for one of PLG’s new main clients, taking responsibility for new regulatory activities related to France and the EU for this client.

About us & Responsibilities

• Provide guidance and support to manage submissions and requests from the main client regarding France.
• Contribute to regulatory activities including pre-licensing, registration, and post-approval applications.
• Assist with the preparation of Marketing Authorization Applications (MAAs).
• Prepare and submit documentation for post-approval applications like Type IA, IB, II, Renewals, MAH Transfers/COAs.
• Manage artwork generation, labelling, and update of product information, ensuring compliance with packaging and labelling standards.
• Respond to internal requests for technical/regulatory information.
• Ensure compliance with regulatory processes for audits.
• Stay updated on national and European guidelines/legislation.
• Use software tools like Microsoft Office, Veeva Vault, LorenZ, Trackwise, PromoMat for documentation and data management.
• Perform regulatory administration duties and track submissions and approvals.
• Contribute to KPI and metrics data entry in PLG tools.

Qualifications

• Bachelor’s Degree in Life Sciences, preferably Pharmacy (PharmD).
• Minimum 3 years of experience in Regulatory Affairs within a pharmaceutical company or service provider.
• Experience with FR LifeCycle Maintenance (LCM), and ideally EU LCM.

Skills

Technical skills:

• Experience with lifecycle maintenance activities for drug products in FR and EU markets.
• Knowledge of French pharmaceutical regulations, medical devices, biotech, and cosmetics.
• Strong computer skills, project management experience, and familiarity with registration processes.
• Fluency in French and English.

Soft skills:

• Excellent communication, organizational, and coordination skills.
• Ability to work under tight deadlines, independently and within a team.
• Attention to detail and solution-oriented mindset.

About us

ProductLife Group offers regulatory outsourcing and consulting services globally, with offices across Europe, Middle East, Asia, Africa, Latin America, and North America. Founded in 1994, we are committed to professional growth and supporting our employees' development. Join us if you are enthusiastic, challenge-driven, and eager to grow professionally.