Site Name: Switzerland - Nyon, Home Worker - GBR, UK - London - Brentford, UK - Surrey - Weybridge Posted Date: Jan 19 2022 The purpose of this role is to provide regulatory leadership, governance and expertise to one sub-category, brand or a portfolio of products such that our products are successfully introduced or maintained Globally. In this role the individual will build a network of collaborative relationships within the sub-category and LOCs and ensure all regulatory requirements are met for both new innovation and existing products according to GSK Values. In this role an individual may also manage a small team for which they will set a compelling vision and deliver against the sub-category strategy and mission. The role may require the individual to provide specialist regulatory advice across the Category and Function. Acts as a Business Partner and provides regulatory advice across sub-Category/significant portfolio on all aspects of drug/cosmetic/devices/foods and supplements (dependent on category) development and regulatory requirements, both current and future. Provides regulatory direction for a sub-category/significant portfolio of products. Develops novel regulatory strategies and influences approaches in order to secure competitive approvals and speed to market in conjunction with LOC regulatory teams. Communicates influences and negotiates effectively with cross-functional internal and external groups at all levels. May lead an efficient and well-motivated small team; including effective people development. Ensure appropriate prioritization and resourcing of projects and delivery of high quality regulatory files to agreed timelines Leads non-product related activities, both in the function and cross functionally, in order to direct new policy or pioneer new processes or improvements to GSK's competitive advantage. Influence the external regulatory environment through networking with key individuals, identifying opportunities and influencing guidelines. May act as GSK representative to external groups for specific topics (e.g. AESGP, Cosmetics Europe) Support the development of the strongest claims possible aligned to consumer insight and within the regulations, ensuring risks are appropriately addressed and communicated within Copy Review Committee. In conjunction with the category regulatory CMC lead, ensure support for the full life cycle of products, including: maintenance activities; Design to Value, complexity reduction, value engineering initiatives; change controls, etc. with supply chain and technical excellence Oversees compliance in all actions by ensuring global, regional and local processes, policies, SOPs and working instructions are adhered to. Medical devices Accountabilities: For Medical Devices (all classes according to 93/42/EEC as amended and Medical Device Regulation (EU) 2017/745 as amended) for which the Senior Manager Regulatory Affairs Category is responsible or acting as back-up ensuring among others: Acting as a delegate for the Director Category Regulatory Affairs for the approval of technical files together with the Legal Manufacturer representative. Approval and Signature of Declaration of Conformities (together with the Legal Manufacturer representative), and other necessary declarations and statements necessary for regulatory activities Medical Device technical documentation (MDTF) creation, update and maintenance as per GSK Quality System/Procedures and in the relevant Consumer Healthcare electronic document management system (eDMS) ensuring among others: Ownership and coordination with functions of Risk management prior or post CE Marking Supervision and approval of MDTF at creation or during update in case of changes (both significant and non-significant. Includes labelling texts and instructions for use for Medical Devices updates) Timely periodic reviews as per Quality Management System requirements Delivery of regulatory evaluation / strategy and MDTF update in case of non-technical changes (both significant and non-significant). Technical changes are handled by GRA CMC team. Regulatory communication with Notified Body, including initial MDTF and input to significant changes submissions, coordination of answers to questions from Notified Body / Competent Authorities / Health Authorities Representation of GRA during audits with MDTF or Medical Devices Regulatory activities in scope Why You? Basic Qualifications: We are looking for professionals with these required skills to achieve our goals: Bachelor's Degree in the areas of Life science/Pharmaceutically-related science (Chemistry, Pharmacy, Biochemistry, Biology, Medical Engineering) Minimum 6 years' experience in Regulatory Affairs Preferred Qualifications: If you have the following characteristics, it would be a plus: Advanced degree in Pharmacy, Chemistry, Biology, Medicine, or similar discipline. Experience at a large global pharmaceutical or vaccines company Experience leading global teams Why GSK? Our values and expectations are at the heart of everything we do and form an important part of our culture. These include Patient focus, Transparency, Respect, Integrity along with Courage, Accountability, Development, and Teamwork. As GSK focuses on our values and expectations and a culture of innovation, performance, and trust, the successful candidate will demonstrate the following capabilities: Agile and distributed decision-making - using evidence and applying judgement to balance pace, rigour and risk Managing individual and team performance. Committed to delivering high quality results, overcoming challenges, focusing on what matters, execution. Implementing change initiatives and leading change. Sustaining energy and well-being, building resilience in teams. Continuously looking for opportunities to learn, build skills and share learning both internally and externally. Developing people and building a talent pipeline. Translating strategy into action - a compelling narrative, motivating others, setting objectives and delegation. Building strong relationships and collaboration, managing trusted stakeholder relationships internally and externally. Budgeting and forecasting, commercial and financial acumen. *LI-GSK If you require an accommodation or other assistance to apply for a job at GSK, please contact the GSK Service Centre at 1-877-694-7547 (US Toll Free) or +1 801 567 5155 (outside US). GSK is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class. 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