Head Of Regulatory Policy & Intelligence M - W H/F Servier

Reporting to the Head of Worldwide Regulatory Affairs, the Head of Regulatory Policy and Intelligence contributes to the forward-leaning vision for WRA by anticipating, analyzing and communicating future trends in the Global Regulatory environment within Servier WRA scope of operation.

MISSION

The Head Regulatory Policy and Intelligence is expected to lead the WRA Regulatory Policy and Intelligence function, including management of 2 direct reports. As part of Worldwide Regulatory Affairs and a member of the WRA Leadership Team, the Head of Regulatory Policy and Intelligence provides leadership to ensure science and risk-based informed decision making on current and future R&D projects considering the evolving regulatory environment.

MAIN FOCUS

- Lead the WRA Regulatory Policy and Intelligence function within Servier

- Ensure matters of strategic interest are identified: analyzed for impact to Servier, considered for Servier R&D and business decisions

- Draw on existing Subject Matter Expertise and resources throughout Servier as well as developing external resources, lead the forward-leaning Voice for WRA Regulatory matters

- Ensure regulatory intelligence gathered, assimilated, analyzed and communicated on key Regulatory matters.

- Lead primary liaisons with Health Authorities and Trade Associations on regulatory policy discussions

- Optimize the use of tools for information sharing on Regulatory Policy and Intelligence matters throughout Servier

- Seek opportunities and lead initiatives for efficiency and effectiveness across Servier for shared tools and information sharing

MAINS RESPONSIBILITIES

- Accountable for the strategic alignment for Regulatory Policy and Intelligence matters within the scope of Worldwide Regulatory Affairs

- Provide leadership, oversight, direction for regulatory trends for Servier within the scope of Worldwide Regulatory Affairs.
- Lead the Global Regulatory Intelligence Group (gathering Corporate Competitive Intelligence, EU Public Affairs, Denim representative, Subject Matter Experts (SME) who act as Servier referents) to:
o Ensure that the Regulatory Affairs' RI topics of excellence are aligned with other functional areas and communicated to other functions,
o Align Servier position regarding policies evolution and define policy positions. Ensure appropriate representation in key Trade Associations to progress Servier positions.

o Gather information and provide an oversight of policy trends to the Regulatory leadership team and Servier executive management,
o Make advice regarding Regulatory Intelligence monitoring/analyzing tools, and Regulatory Intelligence processes.
- Accountable for the gathering of information for relevant benchmark surveys for Regulatory Affairs (with the support of relevant SME).
- Ensure preliminary analysis, organization of SME review of draft of regulatory guidance and other significant regulatory precedence.
- Analyze and communicate intelligence to identify trends that may impact company business.
- Organize and consolidate the Regulatory Intelligence information (on regulatory requirements impacting global drug development and submission strategy), with SME network. Sharing changes with concerned SME and ensuring that the adequate action plans are set up.

- Lead the development and updates of internal Regulatory Intelligence processes and execution.
- Ensure regulatory intelligence analyses on key Regulatory matters are performed and communicated.
- Assist with drafting of comments for submission to Industry organizations, Health Authorities, and other stakeholders
- Ensure RI monitoring, gathering, and analyzing of publicly available and experience based regulatory information to develop a strategy for time- and cost-efficient drug development. Communicate effectively to internal stakeholders.
- Establish and lead the cross-functional committees with Subject Matter Experts within the scope of WRA throughout Servier who act as referent/advisor for Project Teams/Global Regulatory Teams.
- Assist the RI persons of excellence or Regulatory Regional Leads while synthetizing information from regulatory requirements databases, as well as from interactions with vendors and local country.
- Lead and optimize the WRA regulatory intelligence external data /information platform(s).

PROFILE :

- Degree in relevant scientific discipline or equivalent experience Master of Sciences M/S, Pharm D, PhD/MD preferred
- 10 Years' Experience working in a direct or related regulatory policy and intelligence function
- English fluent
- Strong analytical skills demonstrated long-term level vision
- Demonstrated success working within regulatory policy and intelligence function
- Demonstrated knowledge of global regulatory procedures and requirements throughout product development
- Excellent critical thinking and problem-solving skills
- Ability to anticipate and current and future IT potential
- Ability to adapt leadership styles to the situation on hand
- 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
- Ability to direct, organize and manage external contracting companies
- Team Orientation and Shared Accountability- establishing and maintaining cross-functional interactions and effective negotiation; commitment to team ownership for all issues and solutions
- Participative Management - ensure that decisions are made at appropriate levels; identify appropriate opportunities for engaging and contributing to the development of policies and processes
- Leadership through Influence: Ability to provide clear direction through gathering, analyzing and communication important information throughout WRA and Servier
- Coaching and Developing Other Colleagues - Demonstrated ability to mentor, share experience and expertise, engage in dialogue and resolution of issues
- 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.