Pierre Fabre is the 2nd largest dermo-cosmetics laboratory in the world the 2nd largest private French pharmaceutical group and the market leader in France for products sold over the counter in pharmacies.

Its portfolio includes several medical franchises and international brands including Pierre Fabre Oncologie Pierre Fabre Dermatologie Eau Thermale Avène Klorane Ducray René Furterer A-Derma Naturactive Pierre Fabre Oral Care.

Established in the Occitanie region since its creation and manufacturing over 95% of its products in France the Group employs some 10000 people worldwide. Its products are distributed in about 130 countries.86% of the Pierre Fabre Group is held by the Pierre Fabre Foundation a government-recognized public-interest foundation while a smaller share is owned by its employees via an employee stock ownership plan.

In 2019 Ecocert Environment assessed the Groups corporate social and environmental responsibility approach in accordance with the ISO 26000 sustainable development standard and awarded it the Excellence level.

Pierre Fabre is recognized as one of the Worlds Best Employers 2021 by Forbes. Our group is ranked in the Top 3 in the cosmetics industry and in the Top 10 in the pharmaceutical industry worldwide.

Your mission

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.

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 theinternational regulatory strategyfor new registrations lifecyle management and business development activities
• Coordinating and supportinglocal regulatory affiliates and partners
• Ensuringalignment of regulatory priorities planning compliance oversight and franchise budgetwithin WRA

Your role within a pioneering company in full expansion:

1. International Regulatory Strategy & Execution

• Develop aholistic visionfor franchise internationalization including lifecycle management and new market opportunities
• Anticipate analyse and proposeregulatory strategiesfor product registrations and maintenance across markets
• Coordinate theevaluation implementation and planningof regulatory strategies with relevant stakeholders
• Ensure thatinternational regulatory requirements and impactsare integrated into the overall global product regulatory strategy
• Represent your scope inglobal project/product teamsand act as the primary regulatory contact for international markets

2. Coordination with Local Regulatory Contacts & Partners

• Providestrategic and operational supportto local RA contacts (internal affiliates or external partners)
• Ensureeffective implementationof the global internationalization strategy and registration plans at local level
• Build and maintainclose relationshipswith 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 trackingof regulatory activities
  • Oversight of regulatory complianceand coordination of associated action plans
  • Preparation monitoring consolidation and communicationof the regulatory budget for your franchise
• Provide operational back-up to RA project managers when needed and be able totemporarily cover critical activities if required

4. Cross-Functional & Transversal Activities

• Act as aRegional 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 ofmulti-franchise initiatives
• Ensure close collaboration with other WRA teams and related functions
• Provideregulatory advice and supportto other Corporate departments for your franchise and markets

5. Regulatory Intelligence Risk Assessment & Continuous Improvement

• Take into account all relevantregulatory changescommunicated by the Regulatory Intelligence team
• In collaboration with Regulatory Intelligence and Product LCM Leaders:
  • Analyse and share theimpactof new or evolving regulations
  • Assessassociated risks
  • Propose adjustments to theinternationalization strategywhen needed
• Contribute to thedevelopment and optimisationof Regulatory Affairs processes (SOPs best practices tools knowledge sharing etc.)

6. Contribution to the Global Regulatory Affairs Community

• Actively participate indepartment meetings contributing to agenda topics and decision-making
• Helponboard and train new team membersin your areas of expertise in line with onboarding plans set by management
• SupportWRA 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.)
• Appropriatelyescalate and direct anypharmacovigilance-relevant casesto the PV function and ensure they are handled and anyquality complaints or suspected counterfeiting casesto 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 inPharmacy Life Sciences or equivalent
• Significant experience (typically 710 years)in Regulatory Affairs within the pharmaceutical industry
• Proven track record ininternational markets(emerging markets APAC LATAM Middle East/Africa)
• Experience inleading regulatory strategyfor a product portfolio or franchise

• Strong knowledge ofglobal regulatory frameworksand requirements for medicinal products
• Demonstrated ability todefine and execute regulatory strategiesacross multiple countries/regions
• FluentEnglish(spoken and written); additional languages are an asset

We are convinced that diversity is a source of fulfillment social balance and complementarity for our employees which is why our offers are open to all without restriction.