Regulatory Affairs Specialist (Biopharmaceutical)

TL;DR

Regulatory Affairs Specialist (Biopharmaceutical): Defining and executing global regulatory strategies for specialist care therapeutic areas with an accent on European lifecycle management and health authority interactions. Focus on managing MRP/DCP and centralized procedures, coordinating dossier filings, and ensuring compliance with EMA and other national authorities.

Location: Based in France, with possibility to work remotely

Company

International research-focused biopharmaceutical group with 90 years of experience operating in over 30 countries.

What you will do

• Serve as the regional/local regulatory lead and primary point of contact for EU national authorities and the EMA.
• Develop and execute global health authority (HA) interaction and engagement plans for assigned products.
• Lead regulatory subteams to ensure NDA, BLA, MAA, and variations filings meet strict project timelines.
• Collaborate with Project Managers to develop core global dossiers and ensure submission alignment.
• Support GMP, GCP, and GPV inspections conducted by health authorities.
• Provide regular project and submission status updates to the Global Regulatory Team (GRT).

Requirements

• Experience in regulatory lifecycle management in Europe, specifically with MRP/DCP and centralized procedures.
• English: C1 (Fluent) required
• Must be based in France
• Excellent attention to detail regarding data consistency and traceability in submission documents.
• Ability to work independently and collaboratively within multidisciplinary teams.

Nice to have

• Experience interacting with the FDA.
• Experience working with biological products.

Culture & Benefits

• Comprehensive healthcare programs and competitive salary package with performance bonuses.
• Flexible working arrangements and remote work options.
• Work-life balance initiatives and robust relocation support.
• Dynamic and friendly environment with dedicated access to professional resources and training.