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Posted on : 10 April 2017
Shire is the leading global biotechnology company focused on serving people with rare diseases and other highly specialized conditions. We strive to develop best-in-class products, many of which are available in more than 100 countries, across core therapeutic areas including Hematology, Immunology, Neuroscience, Ophthalmics, Lysosomal Storage Disorders, Gastrointestinal/Internal Medicine/Endocrine and Hereditary Angioedema; and a growing franchise in Oncology.Our employees come to work every day with a shared mission: to develop and deliver breakthrough therapies for the hundreds of millions of people in the world affected by rare diseases and other high-need conditions, and who lack effective therapies to live their lives to the fullest.PRIMARY ROLEUnder the direction of the Head EU Regulatory Strategy Group, the EU Regulatory Strategy Team Lead is accountable for defining and owning the European regulatory strategy for products within a defined therapeutic area. This role will provide regulatory strategic leadership and insight into the assigned therapeutic area.For products where the individual acts as the strategy lead, they are also responsible for executing the regional regulatory strategy pertaining to the development, registration and regulatory compliance of Shire products in the EU and Switzerland as dictated by Shire business objectives. This will include interacting with the EMA and national Regulatory Agencies in the EU Member States as needed to ensure timely submission and approval for Shire products in these markets.ESSENTIAL FUNCTIONS: " Accountable for defining the EU regulatory strategy for assigned products within the assigned therapeutic area (maintaining and extending Shire product registrations in EU markets). Collaborates closely with all other key GRA stakeholders (including but not limited to, global regulatory leads, advertising and promotion, labeling, CMC, regulatory operations, international regulatory team and regulatory staff in the EU LOCs) to ensure that all aspects of the regional strategy is coordinated and considered. " Under direction of Head EU Regulatory Strategy Group, designs EU regulatory strategies for the products that they are accountable for, in close collaboration with GRL to obtain, maintain and extend Shire product registrations in Europe " Leads meetings with European Health Authorities aligned with global strategy and information request from the Global Regulatory Teams (GRT) " Communication and collaboration with the EU LOC team to ensure all parties are informed of all activities directly affecting their market. " Oversees direct reports within the assigned therapeutic area. This includes ensuring oversight and providing overall guidance on the regulatory strategy for all products included in the therapeutic area. " Actively trains and mentors direct reports, providing support to the development plans for the direct reports. " Leads cross-functional submission teams to ensure creation and submission of high quality regulatory documents (MA, Briefing documents, Variations, ODD, PIP, SA, responses to list of questions and other relevant regulatory filings) within defined timelines as per company objectives " Acts as regulatory lead for CTA applications conducted in the European region, coordinating with the assigned CRO and functional stakeholders to ensure the timely submission, approval and compliance of all CTA applications. " Ensure appropriate contacts with relevant regulatory agencies, especially the European Medicines Agency, SwissMedic and regulatory agencies in the EU member states to ensure the regulatory applications are approved in a timely manner. " Ensures that the approval is communicated to appropriate functions to allow implementation. " Remains knowledgeable about current regulations and guidance, interprets and notifies appropriate personnel, " Provides support to GXP inspection activities as required. " Ensures all regulatory documentation is stored within Shire systems / databases in accordance with Shire standards Remains knowledgeable about current regulations and guidance, interprets and notifies appropriate personnel, " Provides support to GXP inspection activities as required. " Ensures all regulatory documentation is stored within Shire systems / databases in accordance with Shire standardsEDUCATION & EXPERIENCE REQUIREMENTS: " Life sciences degree preferred. " Minimum of 10 years experience in drug/biologics development the EU pharmaceutical and biotechnology industry or Government Health Agency, " Experience in biologics, drug safety, pharmacovigilance and/or risk management preferred.KEY SKILLS & COMPETENCIES: " Knowledge of EU regulatory requirements and ability to use precedent and previous experience to develop creative approaches to achieving commercial goals. " Previous line-management experience is essential " Ability to challenge self and others to overcome barriers and deliver high quality solutions to the business. " Knowledge of the drug development process and laws and regulations affecting pharmaceutical development in EU region. Prior experience and a track record of success in working with EMA & national agencies in the EU required. " Must be able to work in a fast paced environment with demonstrated ability to juggle multiple competing tasks and demands. " Excellent interpersonal, communication, analytical, and organizational skills.
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