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Job Details

Director Global Regulatory Affairs Team Leader

Company name
Genzyme Corporation

Location
Swiftwater, PA

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The Global Regulatory Team Leader (GRTL) is part of the Global Regulatory Affairs (GRA) organization within the Sanofi Pasteur Global Business Unit (GBU). He\/she is accountable for developing long and short-term regulatory strategies for the projects and products under his\/her accountability. 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 will 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. The GRTL may 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. 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 function s (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), 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. 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 GRT to develop and maintain the core dossier\/Product Reference File. 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.\u00a0 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 Education 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 especially in development phase. Demonstrated knowledge of microbiology, immunology, virology or bacteriology. Experience working on Global Project Teams preferred Proven record of successful registrations preferred Ad-hoc management skills Languages: English fluent required (Other optional) Experience\/Professional Requirement 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 #LI-SA Sanofi US Services, 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. 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, Empowering Life

Company info

Genzyme Corporation
Website : http://www.genzyme.com

Company Profile
Genzyme is committed to discovering and delivering transformative therapies for patients with rare and special unmet medical needs, providing hope where there was none before. Corporate Overview Genzyme has pioneered the development and delivery of transformative therapies for over 30 years. Founded in 1981 in Boston, Massachusetts, Genzyme evolved from a tiny start-up with just a handful of employees to one of the world's leading biotech companies. Acquired by Sanofi in 2011, Genzyme now benefits from the reach and resources of one of the world’s largest pharmaceutical companies, with a shared commitment to improving the lives of patients. We've kept our roots in the Boston area: our headquarters, Genzyme Center, is located in Cambridge, Massachusetts, home to venerable universities, teaching hospitals, and a thriving biotechnology community. But we also operate in every other region of the globe.

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