Director, Labelling Strategy & Development, Therapeutic Area Lead
Site Name: Belgium-Wavre, UK - Hertfordshire - Stevenage, UK - London - Brentford, USA - North Carolina - Research Triangle Park, USA - Pennsylvania - Upper Providence Posted Date: Jul 13 2021 Are you an industry regulatory professional interested in a key strategic labelling role for an exciting portfolio of products/assets? If so, the Director, Labelling Strategy & Development, Therapeutic Area Lead (Vaccines) is an exciting opportunity to explore. The role: The GSK Labelling Strategy and Development group requires a Therapeutic Area Lead who will have portfolio responsibilities for GSK Vaccine assets. They will have line management responsibility for a team focused on the initiation and development of labelling (core datasheets, USPI, EU SmPC) in alignment with the Target Vaccines Profile (TVP) and regulatory requirements for an exciting pipeline of development assets as well as a portfolio of marketed vaccines still in early life cycle. The Vaccine labelling group includes staff based in US, Belgium and Italy and is part of a strategic labelling department including 2 other therapy areas, Oncology and Specialty, comprised of primarily US-based and UK-based staff. This role can be based in US, UK, or Belgium. The portfolio will require oversight of global product information for prescription products and provision of advice to GSK teams on labelling governance requirements/ processes and on global Health Authority regulatory requirements. Leads will interact with senior stakeholders in R&D, Regulatory, Safety, and Commercial. They will be accountable for providing creative approaches/recommendations to product labelling that meet corporate goals while maintaining compliance with relevant laws and regulations. Accountable for management of R&D labelling process for all development and marketed products in designated therapeutic area area(s). Interfaces directly with GSK senior management, functional experts, on business strategy and labelling content. Critically evaluate the data upon which labelling statements are based so as to help ensure clinical relevance and regulatory acceptance. Negotiates resolution of complex regulatory and scientific issues, manages multiple projects simultaneously, and employs sound judgment in solving complex problems and issues. Internally, influences key proposed guidelines and regulations to shape external environment. Partner with GSK Global Labelling (operational group) to effectively implement process changes and quality improvements. Line manage, recruit, and motivate staff within the Labelling Strategy & Development team. Contribute to the leadership of Labelling Strategy & Development as part of its Leadership Team including Head, Labelling Strategy and Development and 2 TA Leads for Oncology and Specialty Why You? Basic Qualifications: At least 7 years of regulatory experience with line and matrix leadership experience. In-depth Labelling knowledge and experience. Bachelor's Degree or work experience equivalent. Preferred Qualifications: Post-graduate degree, preferably PharmD or PhD in science or health related area. Extensive regulatory experience along with thorough understanding of drug development and commercialization processes. Strong ability to rapidly and critically evaluate clinical/scientific data in the context of labelling regulations. Interpersonal, presentation and communication skills with internal and external networks. Influencing skills. Why GSK? GSK is a place where outstanding people do amazing things. As a science-led global healthcare company, we exist to help people do more, feel better, live longer. This special purpose - along with our goal of being one of the world's most innovative, best performing and trusted healthcare companies - helps us attract some of the best and brightest minds in the world. We take pride in providing access to all and continually focus on our opportunity and obligation to do more to improve inclusion and diversity: for our people inside GSK; in the way we do business; and in the communities where we operate. We want our company to be a place where diversity of people and thought is valued everywhere and where we're all able to be ourselves and feel a sense of belonging. An inclusive organization where we all feel valued, engaged and supported, knowing that our work makes an important contribution to our mission. Reinforced by our clear values and expectations, it is part of our DNA. Together we achieve extraordinary things for our patients and consumers, who rely on us each and every day. 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