Hybrid Regulatory Affairs Franchise Leader – International Markets

at Pierre Fabre Group

• Job title: Regulatory Affairs Franchise Leader – International Markets
• Job type: Full Time
• Experience level: Senior
• Salary: Not specified
• Degree requirement: Bachelor's Degree
• Location requirements: Hybrid, Toulouse, France

About the role

• Regulatory Affairs Franchise Leader driving global regulatory strategy across APAC, MEA, Eastern Europe, and LATAM for Pierre Fabre's pharmaceutical products.

Responsibilities

• Develop a holistic vision for franchise internationalization, including lifecycle management and new market opportunities
• Anticipate, analyse and propose regulatory strategies for product registrations and maintenance across markets
• Coordinate the evaluation, implementation and planning of regulatory strategies with relevant stakeholders
• Ensure that international regulatory requirements and impacts are integrated into the overall global product regulatory strategy
• Provide strategic and operational support to local RA contacts (internal affiliates or external partners)
• Ensure effective implementation of the global internationalization strategy and registration plans at local level
• Build and maintain close relationships with key local regulatory contacts
• In collaboration with RA project Managers and other stakeholders, coordinate: Alignment and arbitration of priorities, in line with WRA and Franchise objectives
• Planning and tracking of regulatory activities
• Oversight of regulatory compliance and coordination of associated action plans
• Provide operational back-up to RA project managers when needed, and be able to temporarily cover critical activities if required
• Act as a Regional Champion, as assigned by the Head of International deployment, contributing to cross-product or transversal activities
• Analyse and share the impact of new or evolving regulations
• Assess associated risks
• Propose adjustments to the internationalization strategy when needed
• Contribute to the development and optimisation of Regulatory Affairs processes (SOPs, best practices, tools, knowledge sharing, etc.)
• Actively participate in department meetings, contributing to agenda topics and decision-making
• Help onboard and train new team members in your areas of expertise, in line with onboarding plans set by management
• Contribute to enhancing visibility and understanding of Regulatory Affairs within the company

Requirements

• University degree in Pharmacy, Life Sciences or equivalent
• Significant experience (typically 7–10+ years) in Regulatory Affairs within the pharmaceutical industry
• Proven track record in international markets (emerging markets, APAC, LATAM, Middle East/Africa)
• Experience in leading regulatory strategy for a product portfolio or franchise
• Strong knowledge of global regulatory frameworks and requirements for medicinal products
• Demonstrated ability to define and execute regulatory strategies across multiple countries/regions
• Fluent English (spoken and written); additional languages are an asset.

Benefits

• Incentives
• profit-sharing
• Pierre Fabre shareholding with matching contribution
• health and provident insurance
• 16 days of holidays (RTT) in addition to 25 days of personal holidays
• public transport participation
• very attractive CE