Specialist Care Therapeutic Area, Global Regulatory Affairs and Patient Safety - Temporary (Biopharma)

Location: Based in France, with remote work possible

Company

International research-focused biopharmaceutical group developing and marketing innovative medicines across multiple therapeutic areas.

What you will do

• Contribute to global regulatory strategy and ensure product development and lifecycle plans align with core product labelling.
• Serve as a regional or local regulatory lead and liaise with national health authorities in EU countries and the EMA.
• Develop health-authority engagement and interaction plans, including preparation meetings and accurate communication tracking.
• Lead regulatory subteams and coordinate NDA, BLA, MAA, extension, variation, and renewal submissions against project timelines.
• Collaborate with project managers and global regulatory team members on core dossiers, regulated documents, and submission updates.
• Support operational compliance activities and GMP, GCP, and GPV inspections.

Requirements

• Experience in regulatory lifecycle management in Europe, particularly MRP, DCP, and centralized procedures.
• Fluent English required.
• Excellent attention to detail, data consistency, traceability, and alignment across submission documents.
• Proactive problem-solving skills and the ability to work independently and collaboratively in multidisciplinary teams.
• Ability to work from France is required; remote work is possible.

Nice to have

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

Culture & Benefits

• Temporary contract covering maternity leave.
• Access to development resources and training.
• Comprehensive healthcare programs and work-life balance initiatives.
• Flexible working arrangements, remote work options, relocation support, and tax assistance for foreign colleagues.
• Competitive salary package with performance bonuses and benefits.