Senior Regulatory Affairs Specialist (Pharmaceuticals)

Location: Paris, France

Company

hirify.global provides clinical research services, commercial insights, and healthcare intelligence for the life sciences and healthcare industries.

What you will do

• Lead country-level regulatory activities for medicinal products and ensure compliance with local requirements.
• Prepare, coordinate, and submit lifecycle management documentation, including variations, renewals, notifications, line extensions, marketing authorization holder transfers, and new applications.
• Act as a regulatory contact for clients and Health Authorities, providing guidance and driving submissions through approval.
• Maintain compliant and up-to-date product information and regulatory records.
• Review and approve promotional and non-promotional materials, artwork, labelling updates, and packaging components for France.
• Monitor changes in French regulatory legislation, assess business impact, and contribute to process improvements with cross-functional teams.

Requirements

• Bachelor's degree in Pharmacy, Life Sciences, or a related scientific discipline.
• Significant pharmaceutical industry experience in Regulatory Affairs, including post-approval activities and product lifecycle maintenance.
• Strong knowledge of local pharmaceutical legislation, regulatory requirements, and submission procedures.
• Experience with variations, renewals, labelling updates, and marketing authorization maintenance.
• Fluent written and verbal French and English.
• Strong project management, stakeholder management, communication, problem-solving, accuracy, and attention to detail.

Nice to have

• Experience with regulatory information management systems and artwork review tools.
• Advanced MS Office skills.

Culture & Benefits

• Fixed-term employment for a 12-month contract.
• Collaboration with global pharmaceutical companies and cross-functional Medical Affairs, Quality, Commercial, and Global Regulatory teams.
• Opportunity to contribute to healthcare outcomes and regulatory excellence across a diverse medicinal product portfolio.