Regulatory Affairs Franchise Leader - International Markets - F/M

Regulatory Affairs are hiring in Toulouse or Boulogne a key leadership role within our Corporate WRA organisation, working in close partnership with Global RA Project managers, Local RA, Global commercial and business stakeholders, SMEs and other corporate functions.

Regulatory Affairs Franchise Leader – International Markets

As Regulatory Affairs Franchise Leader – International Markets , you will own and drive the global regulatory strategy for your franchise across all territories in APAC, MEA, Eastern Europe, and LATAM.

You will be responsible for:

• Defining and implementing with the support of RA Project Managers the international regulatory strategy for new registrations, lifecyle management and business development activities
• Coordinating and supporting local regulatory affiliates and partners
• Ensuring alignment of regulatory priorities, planning, compliance oversight and franchise budget within WRA

Your role within a pioneering company in full expansion:

1. International Regulatory Strategy & Execution

• 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
• Represent your scope in global project/product teams and act as the primary regulatory contact for international markets

2. Coordination with Local Regulatory Contacts & Partners

• 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

3. Franchise Governance, Planning, Compliance & Budget

• 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
• Preparation, monitoring, consolidation and communication of the regulatory budget for your franchise
• Provide operational back-up to RA project managers when needed, and be able to temporarily cover critical activities if required

4. Cross-Functional & Transversal Activities

• Act as a Regional Champion, as assigned by the Head of International deployment, contributing to cross-product or transversal activities, including (but not limited to): Regulatory intelligence, updates of regulatory handbooks, coordination of multi-franchise initiatives
• Ensure close collaboration with other WRA teams and related functions
• Provide regulatory advice and support to other Corporate departments for your franchise and markets
• Take into account all relevant regulatory changes communicated by the Regulatory Intelligence team
• In collaboration with Regulatory Intelligence and Product LCM Leaders:
• 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.)

6. Contribution to the Global Regulatory Affairs Community

• 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
• Support WRA strategic projects and priorities, according to departmental priorities
• Contribute to enhancing visibility and understanding of Regulatory Affairs within the company (experience sharing, training, procedures, etc.)
• Appropriately elevate and direct any pharmacovigilance-relevant cases to the PV function and ensure they are handled and any quality complaints or suspected counterfeiting cases to the relevant Quality / Security contacts
• Perform any additional duties or missions in other WRA teams, as assigned by management, according to business priorities and urgencies

This position is compatible with teleworking up to 2 days a week according to company rules.

We offer an attractive remuneration/benefits package: 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...

Your skills at the service of innovative projects:

Education & Background

• 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