â– Head Regulatory Science and Policy JPAC
Genzyme
Tokyo
6 日前

Head Regulatory Science & Policy JPAC

Role :

Provide leadership within Sanofi, working collaboratively with both internal and external stakeholders, to advance Regulatory Science and strategically influence the policy environment set by regulatory authorities in JPAC region.

Guide development of policy positions for external influence and for internal product development (as needed). Cooperatively within Sanofi create and execute advocacy strategies to achieve policy goals.

Responsibilities :

  • Develop effective and systematic approaches to bring functional excellence to Regulatory Policy across the Sanofi group in JPAC with emphasis on key markets.
  • Drive best practices and excellence in execution within the department and cross-functionally.

  • Oversee the creation, standardization and implementation of systems / processes to monitor the regulatory environment for changes, and to work with subject matter experts within the company to assess impact on Sanofi’s products and goals.
  • Develop and implement regulatory policy strategies based on regulatory and legislative trends important to Sanofi’s strategy, product portfolio and therapeutic areas.
  • Monitor, identify and assess regulatory policy or policy in its formative stages for relevance and impact to company’s internal processes, drug development and or regulatory and corporate strategies.
  • Effectively communicate impact and bring awareness of business critical issues for informed decision making.

  • Define in collaboration with the Global Head of Regulatory Science and Policy and other internal and external stakeholders those areas of policy interest for Sanofi, and industry at large, that would benefit from clear industry positioning.
  • Provide subject matter expertise on emerging regulatory issues and how the Sanofi group can engage to influence policy outcomes.

  • Organize and facilitate interfaces to propose draft Policy for such identified areas and collaboratively within Sanofi, and external stakeholders as appropriate, prioritize and route it for review and approval through the corresponding governance / clearance process.
  • Routinely communicate and coordinate regulatory policy activities and work products.

  • Bring and advocate Sanofi’s agreed policy positions to those bodies and thought leaders that bear influence in translating it into action (i.
  • e., implement regulatory change and evolution).

  • Work closely and partner with a number of subject matter experts to plan regulatory advocacy positions, strategies and tactics and facilitate engagement with regulators on key topics of interest (influence regulatory authorities in the development and implementation of emerging regulatory policy).
  • Drive effective and efficient collaboratively support to internal Sanofi groups, functions and / or cross-functional teams.
  • Provide leadership and guidance on Policy matters. Strategize and present action plan to address / mitigate future issues.

  • Work with internal staff and outside consultants, as appropriate, to compile a comprehensive picture of regulatory policy in individual countries and regions, including analyses of issues and their impact on the company’s product portfolio.
  • Support regulatory interactions on policy and advocacy issues, including building relationships with key regulatory decision makers.
  • Provide guidance for company relationships with other regulators and decision makers to further expand these relationships.

  • Proactively participate and track key developments from health authorities, trade associations, special interest groups, industry thought leaders and other external parties that are relevant to regulatory activities at Sanofi and industry at large.
  • Communicate regarding specific regulatory trends, analysis, policies and intelligence to different functions. Guide the strategy to understand and mitigate impact.

  • Serve as key liaison, and represent Sanofi as assigned, with trade associations, think tanks, advocacy organizations and regulatory authorities, managing and guiding the strategy for and execution of these interactions.
  • Lead routine and ad hoc meetings within function and cross-functionally.
  • Liaise closely with colleagues (R&D, External Affairs, etc.) leading policy activities in the external environment to ensure regulatory insights and overall alignment on Sanofi position.
  • Conduct ongoing healthcare analyses / forecasting, which requires in-depth knowledge of legislative / regulatory environment.
  • Identify issues that will impact the business now and in the near future with a view to predicting trend. Work collaboratively with other policy / intelligence groups to optimize horizon scanning.
  • Advance regulatory science by contributing to the ideation and development of new tools, standards, and approaches to assess the safety, efficacy, quality, and performance of regulated products.
  • Write, coordinate and / or review commenting on regulatory or legislative initiatives and guidances as appropriate and assigned.
  • Produce regulatory intelligence reports or deliverables as it relates to project or process strategies to further regulatory strategy and decision-
  • making. Prepare and deliver regulatory intelligence alerts, summaries, reports and newsletters on regular schedule highlighting pertinent regulatory activities and potential impact on Sanofi products and businesses.

  • Conduct the initial analysis of commenting opportunities and assist with drafting of comments for submission to industry organizations, Health Authorities and other stakeholders.
  • Work with external parties / consultants as appropriate to define messaging approach and strategy.
  • Keep abreast of internal and external changes, trends, developments and other dynamics relevant to the regulatory environment that may bear influence to Sanofi and propose action plan.
  • Ensure a current view and perspective of internal / external influences and or implication’s to Sanofi’s therapeutic areas and development projects.
  • Work in collaboration with other functional leaders in Regulatory on regulatory policy issues that affect the portfolio.

    Collaborate closely with Government Affairs and other key stakeholders within Sanofi on the development and implementation of regulatory policy goals.

  • Monitor and interpret the environment : strategically monitor / search the external environment in line with divisions, franchises and geographies and bring emerging issues forward for consideration.
  • Analyze and apply relevant intelligence findings in the context of current Sanofi business and project activities. Promote a regulatory intelligence culture that supports a targeted approach to regulations : gather, collect and collate regulatory information that can be used to inform of risks, develop initiatives, identify emerging regulatory issues in R&D, quality, compliance, business, etc.
  • Maintain consistent oversight of deliverables and ensure issues are escalated when needed and encourage resolution at the appropriate level.
  • Play a key role in development and implementation of appropriate systems, processes and standards within Regulatory Science and Policy and within GRA and Sanofi as assigned.
  • Keep all internal customers, partners and stakeholders abreast of progress and provide interim updates on ongoing activities and current initiatives.
  • Act as a member of committees and task forces, etc. as assigned.
  • Act consistently with Sanofi best practices and code of ethics.
  • Experience and skills :

  • Advance life science degree.
  • 10 years experience in the field and / or related areas. Extensive and proven expertise in Regulatory environment in healthcare.
  • Significant understanding of the drug / biologic development and commercialization process.
  • Previous experience working with senior-level members or officials of trade associations or other key groups that influence regional policies.
  • Existing relationship with local / regional government legislators, committees, administrative staff or other key parties or influencers.
  • In-depth familiarity with competitive activity in the field.
  • Experience in participating in, or supporting, global product development or other cross-functional teams.
  • Impeccable ethics and proven ability to demonstrate Sanofi values.
  • Proven leadership skills. Self-motivated, prone to action and results oriented. Provides an engaging and motivating work environment.
  • Ability to lead multiple complex initiatives (short, mid and long-term). Superior time management and organizational skills.
  • Excellent business acumen and strategic agility. Critical thinker. Good judgment and decision making abilities.
  • Outstanding interpersonal and communication / presentation skills.
  • Strong influencing and negotiation skills.
  • At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers.

    We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.

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