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Regulatory Strategist

Company: Sanofi
Location: Bridgewater
Posted on: June 5, 2024

Job Description:

Regulatory Strategist

  • Location: Amsterdam, the Netherlands -About the jobWe are an innovative global healthcare company with one purpose: to chase the miracles of science to improve people's lives. We're also a company where you can flourish and grow your career, with countless opportunities to explore, make connections with people, and stretch the limits of what you thought was possible. Ready to get started?Our team is involved in developing regulatory product strategies for the Immunology and Inflammation therapeutic area, leading regulatory efforts in the development stage and post marketing of drug products. As a key member of the Global Regulatory Team (GRT), and strategic partner to the Global Regulatory Lead (GRL), you will leverage your regulatory expertise to contribute to the definition of the global regulatory strategy, to enable and drive the execution of aligned US, EU and/or global regulatory strategy for assigned projects, including Health Authority interactions.Main responsibilities
    • You will provide regulatory expertise and guidance on procedural and documentation requirements to GRT and cross-functional teams working flexibly within and across regions to ensure the delivery of business objectives
    • Enable the GRL by providing quality regulatory input and position to internal business partners, including but not limited to the clinical development teams, commercial and Global Regulatory Team for assigned projects
    • Liaise with clinical, commercial, and other internal business partners in partnership with the GRL to enable successful regulatory outcomes
    • Contribute to the development of a harmonized, One Sanofi regulatory voice through participation in appropriate committees, forums at the direction of the GRL
    • Contribute to the GRT for assigned projects in alignment with the team's one regulatory voice for providing strategic input on the TPP, business planning, governance, and committees
    • May serve as a regional/local regulatory lead and point of contact with Health Authorities for projects/products in their remit, as needed; Leads the IND/ CTA submission strategy to ensure preparation timelines meet the project timelines for clinical trial initiationAbout you
      • BS/BA degree in a relevant scientific discipline or MSc in Biology, Life Science, or related field
      • At least 6 years of prior pharmaceutical/biotechnology industry experience, including at least 4 years of relevant Regulatory Affairs experience (regionally and/or global) especially in development phase
      • Proactively contribute with curiosity and openness to diverse perspectives
      • Emerging understanding of clinical development of drugs and/or novel biologics products
      • Demonstrate business acumen, leadership, influencing and negotiation skills
      • Effective communication skills, specifically strong oral and written presentation skills preferred
      • Demonstrated ability to handle multiple projects/deliverables simultaneously is preferred
      • Strong sensitivity for a multicultural/multinational environment.
      • Ability to work in electronic document management systems, e.g., Veeva vault is a plusWhy choose us?
        • Bring the miracles of science to life alongside a supportive, future-focused team
        • Discover endless opportunities to grow your talent and drive your career, whether it's through a promotion or lateral move, at home or internationally
        • Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact
        • Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs and at least 14 weeks' gender-neutral parental leavePursue Progress. Discover Extraordinary.Progress doesn't happen without people - people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. You can be one of those people. Chasing change, embracing new ideas and exploring all the opportunities we have to offer. Let's pursue progress. And let's discover extraordinary together.At Sanofi, we provide equal opportunities to all regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, or gender identity. -Watch our and check out our Diversity Equity and Inclusion actions at !#LI-EURPursue progress, discover extraordinaryBetter is out there. Better medications, better outcomes, better science. But progress doesn't happen without people - people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let's be those people.At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, ability or gender identity.Watch our and check out our Diversity Equity and Inclusion actions at !

Keywords: Sanofi, New Brunswick , Regulatory Strategist, Other , Bridgewater, New Jersey

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