Regulatory Policy and Intelligence Lead, Worldwide Regulatory Affairs Expert

il y a 6 jours

GifsurYvette, Île-de-France Servier Temps plein

**About Us**

Servier is a human-sized, international, and independent pharmaceutical group governed by a Foundation. Our unique model is our pride, but above all, it allows us to fully serve our vocation: 'committed to therapeutic progress for the benefit of patients'. Today, we are a global leader in cardiology, and we have chosen to become a focused and innovative player in oncology by 2030, targeting difficult-to-treat cancers and dedicating over 70% of our R&D budget to this area. This challenge is pursued in parallel with the development of our generic activity to ensure access to quality care for all, at a lower cost.

**Our Team**

We are 21,900 passionate people from over 50 nationalities, driven by an entrepreneurial spirit. Every day, we move forward with and for patients, with and for our teams, driven by the desire to care, to dare, to develop, and to engage in order to be useful to those who need us.

**Key Responsibilities**

  • 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 (continued)**

  • Providing insights and advocating for positions on critical global regulatory issues and trends to Research and Development business partners and contributing to a broader policy platform.
  • Representing Servier at key Regulatory Conferences and Symposia, including webinars and events. Providing feedback and impact analysis to WRA and other stakeholders.
  • Developing an internal communication plan of external regulatory landscape trends, legislative changes, and initiatives, including impact analyses and recommendations for action.
  • Providing support in responding to regulatory research questions, providing analyses and recommendations to regulatory strategists to support regulatory and product development decisions.
  • Tracking proposed new legislation (relating to regulatory topics), drafting guidance or external position/white papers, and developing (with RPI head) best practices for circulating proposals to SMEs and responding with comments, impact assessment, or policy position as appropriate.
  • Representing effectively Servier's position on key regulatory committees in Trade Associations or other appropriate professional associations.
  • Providing regulatory views/positions on any policy positions developed within Servier on emerging legislation.
  • Developing regulatory advocacy plans to ensure Servier positions on key regulatory topics are effectively communicated externally.

**Ideal Profile**

  • Qualifications: Degree in a relevant scientific discipline or equivalent experience. Master of Sciences, 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.

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