Global Regulatory Team Leader
Swiftwater, PA;Marcy-l'Etoile;Toronto, ON
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Position Title: Global Regulatory Team Leader (GRTL)
Department: ACEL Platform
Location: Toronto/CA, Marcy L'Etoile/FR or Swiftwater/US
The Global Regulatory Team Leader (GRTL) is part of the Global Regulatory Affairs (GRA) organization within the Sanofi Pasteur Global Business Unit (GBU).
The incumbent will be responsible for the following:
- Accountable for developing long and short-term regulatory strategies for the projects and products under their accountability.
- Accountable for the development as well as life cycle management strategies for the assigned project/products.
- Serving on cross-functional Global project teams and Global Brand Teams, representing Global Regulatory Affairs.
- Lead the Global Regulatory Team (GRT), comprised of several RA members such as Reg CMC, Reg Labeling, RA Regions and Reg OPS etc.
- Develops the global product strategy, in collaboration with the GRT and is accountable for managing all the regulatory aspects of the product(s) throughout the life cycle of the product. The GRTL is accountable for the execution of the global product strategy, including prioritization of the global regulatory product activities.
- Provides the regulatory expertise necessary to develop global registration strategies for regional and local implementation.
- Accountable for the global regulatory strategy development of Health Authorities interactions.
- Lead the regulatory contacts with External third parties and recommend the inclusion of the most appropriate individuals within the company based upon the criticality of the issues to be addressed.
- Assist the Global Project Head and Global Brand Leader to manage joint venture company/companies during the vaccine development and license maintenance and/or territory expansion.
- May lead a transversal regulatory project where all product-related activities justify several GRTLs.
- Be the main contact point between RA and non-RA functions (e.g. Clinical, GMA, PV, Non-Clinical, ComOps Franchise) for product related aspects.
- Be the GRA representative for Product Alert Teams/Crisis teams, as appropriate.
- Presenting/defending their project/product regulatory strategies to key governance committees including but not limited to TPSC (GRA Leadership tem), TARC (R&D governance committee), CRSF (Clinical Regulatory Strategic Forum), PSB (Product Safety Board), DWG (Development Working Group), IDC (Olivier Brandicourt level), VEC (Vaccine Executive Committee), etc.
- May participate in Due Diligence activities (In-licensing or Out-Licensing opportunities) to highlight the future potential for the asset from a regulatory standpoint, identifying regulatory risks associated with such opportunities and ways to mitigate them (e.g. RSV monoclonal Ab partnership with MedImmune).
- Represents GRA as a core member of the cross functional project team and Global Brand team and provides overall regulatory input for the project(s) globally. In this capacity, the GRTL is the single point of contact for the business on regulatory issues for the project(s).
- Ensure the development of robust global regulatory strategies, including Global Submission Strategy (GSS), for their assigned products and will be accountable for developing and maintaining a global regulatory product strategy document (GRPS)
- Work transversally to ensure a properly functional Global Regulatory Team.
- Facilitates the development and implementation of local regulatory strategy working with the regulatory platforms, regions and/or the countries.
- Responsible for prioritizing projects and activities with the GRT for lifecycle management activities (i.e. renewals, variations, new registration expansions).
- Present the global regulatory strategy/position to senior management / governance committees as needed.
- Work with the GRT to develop and maintain the core dossier/Product Reference File.
- Work with the labeling strategists and regional groups to ensure appropriate labeling content based on the clinical program and TPP. The GRTL will also work with the labeling strategist and regions to develop region specific labels.
- Ensure timely communications of relevant topics to the business and up through GRA senior Management. The communication of any HA feedback should be interpreted and the impact on the project assessed.
- Research and analyse regulatory information and maintain current regulatory knowledge to keep abreast of regulatory procedures and changes
- Ensure compliance with all internal and external requirements and procedures and may suggest improvement to operating policies/processes, as appropriate.
- May line manage, and/or coach mentor, junior staff supporting the program.
- Direct interaction/negotiation skills with regulatory authorities (e.g. FDA, EMA, Health Canada, PMDA, Chinese HA etc.)
- Strong strategic skills including the ability to make complex decisions and ability to defend difficult positions
- Solid knowledge and understanding of complex medical and scientific subject matter as well as evolving regulatory policy and guidance
- Excellent coordination skills including planning, organizing and ability to motivate and lead others
- Ability to work well within cross-functional teams and excellent transversal collaboration skills
- Can demonstrate solid oral communication, presentation and writing skills
- Understanding of the Global (including CA, US, EU, WHO, China, Japan in particular) and pharmaceutical market place and familiarity with medical terminology.
- 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
- Ability to identify risks and manage risks through mitigation and communication
- 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 values
Education and Experience
- PhD, Pharm D or DVM or MSc in Biology, Life Science, or related field of study; and a minimum of 5 (five) years of Global Regulatory Affairs experience especially in development phase
- or minimum BSc in Biology, Life Science, or related field of study and a minimum of 8 (eight) years of Global Regulatory Affairs experience especially in development phase.
- Demonstrated knowledge of microbiology, immunology, virology or bacteriology.
- Understanding of the Global (including CA, US, EU, WHO, China, Japan) and pharmaceutical market place and familiarity with medical terminology.
- Experience working on Global Project Teams preferred
- Proven record of successful registrations preferred
- Expereince with negotiations and regulatory authorities audits (e.g. FDA, EMA, Health Canada, PMDA, Chinese HA etc.)
- Ability to work well within cross-functional teams and excellent collaboration skills
Languages: English fluent required (Other optional)
Applications received after the official close date will be reviewed on an individual basis. Internal applicants are required to notify their manager of their application.
Sanofi Pasteur: The world’s leading vaccine company
Sanofi Pasteur, the vaccines division of Sanofi, is the largest company in the world devoted entirely to human vaccines. Our driving goal is to protect people from infectious diseases by creating safe and effective vaccines. Our company distributes more than 1 billion doses of vaccine each year, making it possible to vaccinate more than 500 million people across the globe. Sanofi Pasteur offers the broadest range of vaccines in the world, providing protection against 20 bacterial and viral diseases.
Sanofi is dedicated to supporting people through their health challenges. We are a global biopharmaceutical company focused on human health. We prevent illness with vaccines, provide innovative treatments to fight pain and ease suffering. We stand by the few who suffer from rare diseases and the millions with long-term chronic conditions. With more than 100,000 people in 100 countries, Sanofi is transforming scientific innovation into healthcare solutions around the globe.
Sanofi is an equal opportunity employer committed to diversity and inclusion. Our goal is to attract, develop and retain highly talented employees from diverse backgrounds, allowing us to benefit from a wide variety of experiences and perspectives. We welcome and encourage applications from all qualified applicants. Accommodations for persons with disabilities required during the recruitment process are available upon request.
Thank you in advance for your interest.
Only those candidates selected for interviews will be contacted.
Sanofi, Empowering Life
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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