Global Regulatory Lead Shingrix
Site Name: USA - Massachusetts - Waltham, Belgium-Wavre, USA - Maryland - Rockville, USA - Pennsylvania - Upper Providence Posted Date: Oct 28 2021 Job purpose: As Global Regulatory Lead Shingrix, you will have global responsibility for Regulatory Affairs of a given Project(s)/Product(s), within GSK Vaccines. The purpose of the job is to: Manage regulatory activities in order to obtain Marketing Authorizations for commercial products, obtain the best possible label, and maintain these authorizations. Determine from a strategic and scientific perspective the content of technical, pre-clinical and clinical sections of product specific documents submitted to regulatory agencies worldwide (eg. MAA/BLA, variations/sBLA, Q&A, scientific consultations, Pediatric Investigational Plans) to ensure that these documents meet high scientific standards and regulatory requirements. For cross-product sections or stand-alone documents work with the function to ensure content is aligned with targeted overall profile of the product. Provide input into all development stages of the products within a given product portfolio. Contribute, from an RA perspective, to the establishment of the product development strategy and its execution in order to ensure a complete and rapid development of the asset. Provide robust regulatory advice and plans to the various project teams and advisory bodies to ensure that the business needs are compliant with regulations and/or regulatory advice received from the agencies. Key responsibilities: The role is broad and strategic and has a fundamental impact on the product(s)/project(s) Global Regulatory Lead Shingrix you, Act as, or manage, the single point of Regulatory contact for Project Teams (PTs) and/or Vaccine Leadership Teams (VLTs), as appropriate, plus other internal project related teams (e.g. LTT, SRT etc.) and possibly teams with the rest of GSK corporation; Participate in project discussions and provide strategic, scientific and RA input. Develop the asset specific regulatory strategy on a global scale Global Regulatory Plan (GRP) ownership and accountability; Coordinate the determination of key messages for product/portfolio specific regulatory documents to be submitted to Authorities Ensure that the content of product/portfolio specific regulatory documents is in line with GSK Vaccines (or corporate) objectives Ensure high quality of product/portfolio specific regulatory documents submitted to Authorities and ensures that those documents meet regulatory requirements Provide input to Vaccines Development Plans in order to optimize the label and secure proper alignment of technical, clinical and non-clinical aspects and the use of appropriate regulatory procedures to secure the optimum submission strategy; Communicate relevant asset specific information to enable colleagues (eg. VDL and LOC) to prepare the external environment in a timely fashion; Key driver for the lifecycle of the asset; Act as Point of contact for Regulatory Agencies for asset(s) Ensure efficient interactions with the regulatory authorities to achieve on-time approvals of GSK Vaccines submissions for the asset(s) Coordinate early interactions with key authorities to obtain input on clinical, technical and/or non-clinical development strategy and, as appropriate, on the optimal regulatory pathway to follow to secure registration and/or approval of regulatory submissions for the given asset(s) Ensure in collaboration with the relevant RA functions, as appropriate, the resources to ensure execute the agreed RA plan Lead and manage the Regulatory Team - i.e. direct and indirect reports - responsible for execution of the regulatory strategy for a project/product. Develop and motivate collaborators so to achieve quality output, accountability and recognition across the organization and towards the regulatory authorities. Why you? Basic Qualifications: We are looking for professionals with these required skills to achieve our goals: Ph.D. or M.D in Pharmacy, Chemistry, Biology or Medicine 8+ years significant experience in managing regulatory projects, or appropriate experience. Proven experience and awareness of changes in regulatory guidelines and their impact on regulatory strategy for the particular asset(s) Proven experience in the development of medicinal products and obtaining licenses in different geographical areas. Preferred Qualifications: If you have the following characteristics, it would be a plus: Strategic thinking Proactive leadership to identify issues and mitigation strategies, maximize opportunities, with proven ability to develop collaborative relationships and have high impact and influence Influencing and presentation skills Recognized communication skills, both spoken and written Problem-solving Enterprise thinking Cultural awareness Fluency in French and/or Italian *LI 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, rigor and risk, governance and control, managing ambiguity and paradox. Managing individual performance. Creating a performance culture and driving results, prioritization, execution, delivering performance. Setting strategic direction and leading on-going organizational transformation. Building a resilient organization. Building strong relationships and collaboration in service of common goals, engaging the organization and building trusted external networks for mutual benefit. Managing P&L and capital allocation. 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 Employer and, in the US, we adhere to Affirmative Action principles. This ensures that 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. At GSK, the health and safety of our employees are of paramount importance. As a science-led healthcare company on a mission to get ahead of disease together, we believe that supporting vaccination against COVID-19 is the single best thing we can do in the US to ensure the health and safety of our employees, complementary workers, workplaces, customers, consumers, communities, and the patients we serve. 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