Global Regulatory Team Leader General Medicines
Bridgewater, New Jersey
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Job Purpose/Job Description
Within General Medicines Global Business Unit and Center of Experts, The Global Regulatory Team Leader (GRTL) is part of the Global Regulatory Affairs (GRA) organization within the General Medicines GBU GRTL Team.
- The GRTL is accountable for developing long and short-term regulatory strategies for the projects and products within Cardiovascular portfolio. The GRTL is accountable for the development as well as life cycle management strategies for the assigned project/products.
- The GRTL serves on cross-functional Global project teams and Global Brand Teams, representing Global Regulatory Affairs.
- The GRTL will lead the Global Regulatory Team (GRT), comprised of several RA members such as Reg CMC, Reg Labeling, RA Regions and Reg OPS etc.
- The GRTL 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.
- The GRTL provides the regulatory expertise necessary to develop global registration strategies for regional and local implementation.
- The GRTL is accountable for the global regulatory strategy development of Health Authorities interactions
- The GRTL may lead a transversal regulatory project where all product-related activities justify several GRTLs.
- The GRTL is the main contact point between RA and non-RA functions (e.g. Clinical, GMA, PV, Non-Clinical, ComOps Franchise) for product related aspects.
- The GRTL is the GRA representative for Product Alert Teams/Crisis teams, as appropriate
- The GRTL is responsible for presenting/defending their project/product regulatory strategies to key governance committees including but not limited to TPSC (GRA Leadership team), MRPTC, SLT (Scientific Leadership team meeting) etc..
- The GRTL 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.
Major Activities/Key Responsibilities
- 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).
- The GRTL will 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)
- The GRTL will work transversally to ensure a properly functional Global Regulatory Team. The GRTL facilitates the development and implementation of local regulatory strategy working with the regulatory platforms, regions and/or the countries. The GRTL is responsible for prioritizing projects and activities with the GRT for lifecycle management activities (i.e. renewals, variations, new registration expansions).
- The GRTL is accountable to present the global regulatory strategy/position to senior management / governance committees as needed.
- The GRTL will 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.
- The GRTL will 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.
- The GRTL 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
- PhD, Pharm D or DVM or MSc in Biology, Life Science, or related field of study; at least 5 to 8 years of prior Global Regulatory Affairs experience
- Demonstrated knowledge of Diabetes management is a plus.
- Experience working on Global Project Teams preferred
- Proven record of successful registrations preferred
- Ad-hoc management skills
- Languages: English fluent required , (Other languages optional)
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.
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