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Director Regulatory Science & Policy, NA

Company: SANOFI
Location: Bethesda
Posted on: November 17, 2019

Job Description:

Sanofi ? Director Regulatory Science & Policy, NAJob DescriptionRole:Lead and support Sanofi activities in global regulatory science and policy (GRSP).? Reporting through Global Regulatory Affairs (GRA), the candidate will work collaboratively with both internal and external stakeholders to identify areas important to the Sanofi and pharmaceutical business, advise internal stakeholders on the evolving regulatory policy issues, and influence the developing external regulatory landscape and for internal product development. ?Responsibilities:

  • Monitor emerging regulatory policy issues in assigned areas, including issues arising from North American regulatory authorities, legislatures, within the pharmaceutical industry or elsewhere, and identify those issues likely to impact Sanofi?s R&D pipeline, regulatory strategy or product portfolio.? While assigned areas may change, initial assignments will focus on North American regulatory policy related to CMC, biosimilars and generics, and combination products.?
    • Provide regulatory intelligence to internal stakeholders, including GRA, R&D, Government Affairs, Medical Affairs and Legal. Effectively communicate impact and bring awareness of business critical issues for informed decision making, and work with subject matter experts within the company to assess impact on Sanofi?s products and goals.
      • Coordinate and lead internal teams to develop Sanofi responses and comments on draft legislation, regulations, guidelines and regulatory policies issues.? Liaise closely with colleagues (R&D, External Affairs, etc.) leading policy activities in the external environment to facilitate regulatory input and overall alignment on Sanofi position. Plan and manage interactions and communications with trade associations and health authorities on regulatory policy matters.
        • Lead proactive advocacy efforts for Sanofi?s priority regulatory policy areas.? Consult with internal experts and leadership to identify priority issues.? In collaboration with GRSP team, internal experts and stakeholders, coordinate company policy positions across stakeholder groups, identify or create opportunities for engagement with regulatory authorities and trade associations, and execute on proposed strategies.?
          • 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.
            • Provide support and leadership on additional projects concerning the development, status and impact of regulatory policy issues.? 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.
              • 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.
                  • Act consistently with Sanofi best practices and code of ethics.Experience and skills:
                    • Advanced degree in life sciences, or law; or equivalent experience in pharmaceutical industry or science policy.
                    • 12+ years of experience including 8 years in the pharmaceutical industry, either within government, industry, or consultants. ?Extensive and proven expertise in healthcare regulatory environment.
                    • Familiarity and 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.
                    • 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.Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.#GD-SA#LI-SAAt 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.

Keywords: SANOFI, Germantown , Director Regulatory Science & Policy, NA, Executive , Bethesda, Maryland

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