Nous sommes un groupe pharmaceutique à dimension humaine, international et indépendant, gouverné par une Fondation. Notre modèle, singulier, fait notre fierté mais, surtout, nous permet de servir pleinement notre vocation : « engagés pour le progrès thérapeutique au bénéfice des patients ». Aujourd’hui leader mondial en cardiologie, nous avons choisi de devenir un acteur focalisé et innovant en oncologie d’ici 2030, en ciblant des cancers difficiles à traiter et en y consacrant plus de 70 % de notre budget R&D. Un défi que nous poursuivons en parallèle du développement de notre activité générique pour un accès à des soins de qualité pour tous, et à moindre coût.
Nous ? 21 900 passionnés de plus de 50 nationalités, portés par un esprit d’entreprenariat. Chaque jour nous avançons avec et pour les patients, avec et pour nos équipes, portés par l’envie de prendre soin, d’oser, de nous développer, de nous engager pour être utiles à celles et ceux qui en ont besoin.
Venez vivre et contribuez à faire vivre notre engagement #MovedByYou
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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.
Nous sommes engagés pour l’égalité des chances et le développement des talents dans toute leur diversité. Nous accordons autant de valeur à l’expérience qu’à l’envie de s’engager au quotidien pour être utile au progrès thérapeutique au bénéfice des patients. Si vous vous reconnaissez dans cette offre et ces quelques lignes, saisissez cette opportunité de nous rencontrer.