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
Job title
Regulatory Affairs Franchise Leader – International Markets
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