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(Director) Global Regulatory Team Lead - Vaccine

Company: Principia Biopharma Inc.
Location: Cambridge
Posted on: January 16, 2022

Job Description:

Position Overview:
The Global Regulatory Team Lead (GRTL) within the Sanofi Pasteur Global Regulatory Affairs (GRA) organization is accountable for developing and executing robust global regulatory strategies for pipeline and lifecycle assets to ensure achievement of global regulatory/business objectives of Sanofi's Vaccines Global Business Unit. The GRTL leads and prospectively works with the Global Regulatory Team (GRT) and works with and participates on multi-disciplinary matrixed project/product teams to successfully meet project deliverables. The GRTL reports to the GRA Influenza and RSV franchise lead and is responsible of some Influenza vaccines of the portfolio.
Key Responsibilities:

  • Represents Global Regulatory Affairs (GRA) as a member of the cross functional project/product team and/or Brand team. In this capacity, the GRTL is the single point of contact for the business and R&D on regulatory issues for the project. The GRTL provides regulatory advice and strategy for the project(s)/products and ensures timely execution of regulatory activities.

  • Leads the GRT (RA regions, Regulatory CMC, Regulatory Operations, Regulatory labeling). Ensures effective communication between cross functional project team and the GRT; oversees planning and execution of global regulatory activities and submissions.

  • Ensure development of robust global regulatory strategies for the projects/products and is accountable for developing and maintaining a regulatory strategy document (GRPS). The regulatory strategy addresses the Target Product Profile, regional specific needs, regulatory environment, regulatory risks and mitigations, global submission strategies, and reimbursement strategies as well as life product cycle management strategy. The GRTL will work with the GRT to ensure relevant input from all GRA functions is vetted and included in the regulatory strategy framework.

  • Responsible for developing regulatory strategy information for presentation during leadership governance meetings. The GRTL is accountable for ensuring GRA Sr. Management alignment with strategy, risks and mitigation and for presenting a unified regulatory voice.

  • The GRTL is responsible for ensuring communications from HAs and meetings with HA are fully supported and that minutes are disseminated in a timely manner and properly interpreted, to the project/product teams, the business unit, and GRA Sr. Management.

  • Provide regulatory due diligence assessments of new business opportunities as required.

    Basic Qualifications:

    • 7-10 years pharmaceutical industry experience in R&D, Regulatory or related functions, with at least 5 years working in regulatory affairs (regionally or globally). Regulatory lead experience in US or EU. BA/BS in a scientific discipline or related field of study.

      Preferred Qualifications:

      • Advanced degree preferred.

      • Experience with least one major marketing application (NDA/BLA/MAA/JNDA etc.), or extensive experience with late stage development/marketed products.

      • Licensed product knowledge and experience with post-approval changes is also desired.

        Knowledge, Skills and Other Experience:

        • Strategic thinker.

        • Solid knowledge and understanding of complex medical and scientific subject matter as well as evolving regulatory policy and guidance.

        • Experience / Exposure to vaccines is desired.

        • Direct interaction/negotiation with regulatory authorities (e.g. FDA, EMA, BRDD).

        • Strong strategic skills including the ability to make complex decisions and willingness to defend difficult positions.

        • Excellent operational skills including planning, organizing and ability to motivate and lead others.

        • Ability to work well within cross-functional teams.

        • Can demonstrate solid oral communication and writing skills.

        • Understanding of the Global pharmaceutical market place and familiarity with medical terminology. Understands issues, problems, and opportunities by comparing data from different sources to draw conclusions and then can choose a course of action or develop the appropriate solution.

        • Develops collaborative relationships to facilitate the accomplishment of work goals.

        • Generates innovative solutions in work situations, trying different and novel ways to deal with work problems and opportunities.

        • Shows ability to use appropriate interpersonal styles and techniques and can modify behavior to gain acceptance of ideas or plans.

        • Can build networks to obtain cooperation without relying on authority.

        • Strong sensitivity for a multicultural/multinational environment.

        • Unquestionable ethics, professional integrity, and personal values consistent with the Sanofi.

          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.
          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.

Keywords: Principia Biopharma Inc., Cambridge , (Director) Global Regulatory Team Lead - Vaccine, Executive , Cambridge, Massachusetts

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