Regulatory Policy and intelligence Lead, Worldwide Regulatory Affairs W/M
Il y a 4 mois
Servier is an international pharmaceutical company based in Suresnes governed by a non-profit Foundation (FIRS, Fondation Internationale de Recherche Servier), with the mission to drive therapeutic progress which will serve patient needs. Relying on a solid international presence, R&D, production and subsidiaries’ activities are carried out in nearly 70 countries around the world and drugs are available in 150 countries.
The turnover of the group reaches more than €5.3 billion (2023).
10 countries achieved a turnover of more than 100 million euros. The main contributors in Europe are Italy, France, Romania, Germany and Poland and outside the EU: the United States, China, Russia, Brazil and the Gulf States.
EBITDA* reaches 1 billion euros (2023) (+18% vs 2021/2022).
* (earnings before interest, taxes, depreciation and amortization)
Servier employs more than 21,900 people worldwide, including 4,500 in France.
Entirely independent, Servier reinvests 20% of its total turnover (excluding generics) in Research and Development, a driver of innovation. The priority objective is to reach a profit allowing Servier to maintain this level of investment guaranteeing innovation, independence and future sustainability.
Servier focuses on four therapeutic areas of research: oncology, cardiometabolism, neuroscience and immuno-inflammation. Currently, Servier has more than 36 clinical programs including 15 new molecular entities at different stages of clinical development.
Servier is a key player in cardiology (number 5 worldwide) and oncology has become an absolute priority in recent years: the acquisitions of Shire's oncology activities in the United States in 2018, Biotech Symphogen in Denmark in 2020, then the oncology branch of Biotech Agios Pharmaceutical (US) in 2021 were essential elements in this ambition. They illustrate the implementation of the strategy defined by the Group, which aims to expand its geographic presence and become a key player in oncology.
The laboratory also manufactures quality generic drugs with recognized efficacy. The generic subsidiaries offer a wide range of nearly 1,500 drugs covering most pathologies. These subsidiaries employ around 4,500 people and represent around 25% of our turnover, ie 1.3 billion euros. Generic drugs are manufactured in factories in Europe. The French subsidiary, Biogaran, distributes its drugs in France, Brazil and Nigeria. The markets of the Hungarian subsidiary (Egis) are located mainly in Hungary, Russia, Eastern Europe and Central Europe.
Four research centers are constantly involved in the creation, testing and development of new drugs, which are manufactured and packaged in 16 production centers around the world. 96.5% of the active ingredients of Servier drugs are synthesized in the Bolbec-Baclair plant in France.
In March 2023, the Servier R&D Institute opened its doors in the cross-disciplinary innovation hub at Paris-Saclay. The aim of this Servier R&D Institute at Paris-Saclay is to combine the Group’s innovation potential with a powerful ecosystem and a center of scientific excellence. The objective is to develop Research 4.0; the Group looks to the future in order to anticipate the challenges faced by generations in considering health from a global perspective, keeping the patient at the heart of its concerns.
Faced with the climate emergency and environmental degradation Servier's commitment to the planet encourages us to adopt measures to reduce our greenhouse gas emissions and to strengthen our involvement in favor of biodiversity and the preservation of natural resources. We adopt a global and integrated approach throughout the pharmaceutical value chain. In line with the commitments of the Paris Agreement, Servier's strategy consists in reducing its global CO2 emissions by 25% between 2016 and 2030, i.e. a reduction of 251,282 teq CO2. We have already initiated numerous initiatives on several of our sites: regeneration of solvents, energy renovation of buildings, purchase and on-site production of renewable energy, or even development of maritime transport as an alternative to air transport. As part of a partnership with EcoAct, we also offset part of our incompressible residual emissions by financing projects allowing the capture or limitation of carbon emissions.
The Company’s ambition for 2030:
Servier was founded to serve health. Servier aspires in 2030 to have a meaningful social impact for patients and for a sustainable world. To reach its ambition, Servier relies on a strategy based on the following axes:
• Create a significant positive social impact for a sustainable world.
• Be an innovative player in oncology, neuroscience and immuno-inflammation.
• Be an ever-recognized leader in cardio metabolism and venous disease.
• Perform with a reshaped industrial operations value chain.
• Be an agile organization and a digital performer.
• Be all proud and passionate for our vocation.
The ambitions for 2025 are as follows:
• Launch one new molecular entity every three years
• Become a key player in oncology
• Reach €6 Bn in consolidated revenue
• Increase EBITDA to €1.3 Bn to sustain heavy investment in development.
All employees are driven by shared values and guided by a common vision, sharing a passion for entrepreneurship and committed to therapeutic progress to serve patient needs.
MAIN FOCUS AND CHALLENGES:
The Regulatory Policy and Intelligence Lead is a new position within World Regulatory Affairs (WRA) in Servier. The incumbent reports to the Head, Regulatory Policy and Intelligence and is expected to lead the WRA Regulatory Policy and Intelligence activities. The Regulatory Policy and Regulatory Intelligence Lead will be a strong subject matter expert in regulatory processes, laws, and regulations, with a strong understanding of how regulatory policy is shaped and developed. As part of Worldwide Regulatory Affairs the Regulatory Policy and Intelligence Lead provides leadership to ensure science and risk-based informed decision making on current and future R&D projects considering the evolving US regulatory environment.KEY RESPONSIBILITIES
Providing insights and advocate for positions on critical global regulatory issues and trends to Research and Development business partners and to contribute to a broader policy platform. Represent Servier at key Regulatory Conferences and Symposia, including webinars and events. Provide feedback and impact analysis to WRA and other stakeholders. Develop internal communication plan of external regulatory landscape trends, legislative changes, and initiatives, including impact analyses and recommendations for action. Provide support in responding to regulatory research questions providing analyses and recommendations to regulatory strategists to support regulatory and product development decisions. Track proposed new legislation (relating to regulatory topics), draft guidance or external position/ white papers and develop (with RPI head) best practices for circulating proposals to SMEs and to respond with comments, impact assessment or policy position as appropriate. Represent effectively Servier’s position on key regulatory committees in Trade Associations or other appropriate professional associations. Provide regulatory views/ position on any policy positions developed within Servier on emerging legislation. Develop regulatory advocacy plans to ensure Servier positions on key regulatory topics are effectively communicated externally.IDEAL PROFILE
Qualifications: Degree in relevant scientific discipline or equivalent experience Master of Sciences M/S, Pharm D, PhD/MD preferred. Hard skills: 7-10 Years’ Experience working in regulatory affairs within a regulatory policy and intelligence function or experience of working closely as a regulatory strategist with the regulatory policy and intelligence function and ideally with experience working with Trade Associations. Knowledge of global regulatory procedures and requirements throughout product development. Deep understanding of the regulatory environment, and latest regulations and guidance’s with sound knowledge of intelligence tools and methods. Knowledge and understanding of the current and emerging policy and regulatory science topics and views. English fluent Soft skills: Strong analytical skills demonstrated long-term level vision. Excellent critical thinking and problem-solving skills. Ability to anticipate and current and future IT potential. Collaborative mindset working in multi-functional and multi-geographic teams and networking. Ability to understand and clearly communicate information to non-scientific and scientific individuals. Team Orientation and Shared Accountability– establishing and maintaining cross-functional interactions and effective negotiation; commitment to team ownership for all issues and solutions. Problem Solving - Ability to interpret future trends and regulatory guidelines and queries with respect to R&D project.Whatever your area of expertise, your work within the Servier Group helps advance therapeutic progress for the benefit of patients. You will be part of teams recognized for their scientific excellence and reach your full potential in a professional environment that encourages you to develop yourself. Tailor-made onboarding journeys, mobility opportunities, quality trainings, responsible management, team spirit... All this and more in a workplace focused on your well-being.
At Servier, we are committed to therapeutic progress to serve patient needs. We put the diversity of our employees as a source of richness for the fulfillment of this vocation.
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