Regulatory Affairs Franchise Leader - International Markets -CDI- F/M

<div><div><div><div><div><div><div><h1><span class="emphasis-3"><b><b>Who we are ?</b></b></span></h1><p style="text-align:inherit"></p></div></div></div></div></div></div></div><p style="text-align:left">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.</p><p style="text-align:inherit"></p><p style="text-align:left">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. </p><p style="text-align:left"><br />Established in the Occitanie region since its creation, and manufacturing over 95% of its products in France, the Group employs some 10,000 people worldwide. Its products are distributed in about 130 countries. 86% of the Pierre Fabre Group is held by the Pierre Fabre Foundation, a <span><span><span><span><span class="WKN2">government-recognized</span></span></span></span></span> public-interest foundation, while a smaller share is owned by its employees via an employee stock ownership plan. </p><p style="text-align:left"><br />In 2019, Ecocert Environment assessed the Group’s corporate social and environmental responsibility approach in accordance with the ISO 26000 sustainable development standard and awarded it the “Excellence” level.</p><p style="text-align:left"><br />Pierre Fabre is recognized as one of the &#34;World&#39;s Best Employers 2021&#34; by Forbes. Our group is ranked in the Top 3 in the cosmetics industry and in the Top 10 in the pharmaceutical industry worldwide. </p><p style="text-align:inherit"></p><p style="text-align:inherit"></p><p style="text-align:inherit"></p><p style="text-align:inherit"></p><h1><span class="emphasis-3"><b><b>Your mission</b></b></span></h1><p style="text-align:inherit"></p><p>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.</p><p></p><p>As <b>Regulatory Affairs Franchise Leader – International Markets</b>, you will own and drive the global regulatory strategy for your franchise across all territories in APAC, MEA, Eastern Europe, and LATAM.</p><p></p><p>You will be responsible for:</p><ul><li>Defining and implementing with the support of RA Project Managers the international regulatory strategy for new registrations, lifecyle management and business development activities</li><li>Coordinating and supporting local regulatory affiliates and partners</li><li>Ensuring alignment of regulatory priorities, planning, compliance oversight and franchise budget within WRA</li></ul><p></p><p><b><u>Your role within a pioneering company in full expansion:</u></b></p><p></p><p>1. International Regulatory Strategy &amp; Execution</p><ul><li>Develop a holistic vision for franchise internationalization, including lifecycle management and new market opportunities</li><li>Anticipate, analyse and propose regulatory strategies for product registrations and maintenance across markets</li><li>Coordinate the evaluation, implementation and planning of regulatory strategies with relevant stakeholders</li><li>Ensure that international regulatory requirements and impacts are integrated into the overall global product regulatory strategy</li><li>Represent your scope in global project/product teams and act as the primary regulatory contact for international markets</li></ul><p></p><p>2. Coordination with Local Regulatory Contacts &amp; Partners</p><ul><li>Provide strategic and operational support to local RA contacts (internal affiliates or external partners)</li><li>Ensure effective implementation of the global internationalization strategy and registration plans at local level</li><li>Build and maintain close relationships with key local regulatory contacts</li></ul><p></p><p>3. Franchise Governance, Planning, Compliance &amp; Budget</p><ul><li>In collaboration with RA project Managers and other stakeholders, coordinate:<ul><li>Alignment and arbitration of priorities, in line with WRA and Franchise objectives</li><li>Planning and tracking of regulatory activities</li><li>Oversight of regulatory compliance and coordination of associated action plans</li><li>Preparation, monitoring, consolidation and communication of the regulatory budget for your franchise</li></ul></li><li>Provide operational back-up to RA project managers when needed, and be able to temporarily cover critical activities if required</li></ul><p></p><p>4. Cross-Functional &amp; Transversal Activities</p><ul><li>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</li><li>Ensure close collaboration with other WRA teams and related functions</li><li>Provide regulatory advice and support to other Corporate departments for your franchise and markets</li></ul><p></p><p>5. Regulatory Intelligence, Risk Assessment &amp; Continuous Improvement</p><ul><li>Take into account all relevant regulatory changes communicated by the Regulatory Intelligence team</li><li>In collaboration with Regulatory Intelligence and Product LCM Leaders:<ul><li>Analyse and share the impact of new or evolving regulations</li><li>Assess associated risks</li><li>Propose adjustments to the internationalization strategy when needed</li></ul></li><li>Contribute to the development and optimisation of Regulatory Affairs processes (SOPs, best practices, tools, knowledge sharing, etc.)</li></ul><p></p><p>6. Contribution to the Global Regulatory Affairs Community</p><ul><li>Actively participate in department meetings, contributing to agenda topics and decision-making</li><li>Help onboard and train new team members in your areas of expertise, in line with onboarding plans set by management</li><li>Support WRA strategic projects and priorities, according to departmental priorities</li><li>Contribute to enhancing visibility and understanding of Regulatory Affairs within the company (experience sharing, training, procedures, etc.)</li><li>Appropriately escalate 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</li><li>Perform any additional duties or missions in other WRA teams, as assigned by management, according to business priorities and urgencies</li></ul><p></p><p>This position is compatible with teleworking up to 2 days a week according to company rules.</p><p></p><p>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...</p><p style="text-align:inherit"></p><p style="text-align:inherit"></p><div><div><div><div><div><div><div><h1></h1><h1><span class="emphasis-3"><b><b>Who you are ?</b></b></span></h1><div><div><div><div><div><div><p style="text-align:inherit"></p><div><h1></h1></div></div></div></div></div></div></div></div></div></div></div></div></div></div><p><b><u>Your skills at the service of innovative projects:</u></b></p><p><b>Education &amp; Background</b></p><ul><li>University degree in Pharmacy, Life Sciences or equivalent</li><li><b>Significant experience (typically 7–10&#43; years) in Regulatory Affairs within the pharmaceutical industry</b></li><li>Proven track record in international markets (emerging markets, APAC, LATAM, Middle East/Africa)</li><li>Experience in leading regulatory strategy for a product portfolio or franchise</li></ul><ul><li>Strong knowledge of global regulatory frameworks and requirements for medicinal products</li><li>Demonstrated ability to define and execute regulatory strategies across multiple countries/regions</li><li>Fluent English (spoken and written); additional languages are an asset</li></ul><p style="text-align:inherit"></p><p style="text-align:inherit"></p><p style="text-align:inherit"></p><p style="text-align:left"><i>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.</i></p>