Regulatory Project Manager

Site Name: Poznan Grunwaldzka, Warsaw Posted Date: Dec 23 2022 Regulatory Project Manager – Product Variations At GSK, we’re constantly developing new products and improving our established medicines to better the quality of human life. Ensuring all changes for Finished Product, Intermediate and Drug Substance are properly registered and up to date is essential, and that’s where our CMC (Chemistry, Manufacturing and Control) Product Variations team’s experience and support are crucial. The Team is a part of Content Delivery area and supports GSK portfolio of medicines, for Pharma, Biopharm and Vaccines portfolio, for lifecycle changes and Pharma Supply Chain centrally driven initiatives, by ensuring that the CMC information relating to the quality, safety and efficacy of our products is correct. This is done through the managing of complex submissions and its strategy element, preparation of technical documentation for regulatory changes globally, providing responses to Regulatory Agency questions and expertise in the regulatory requirements for global source changes and CMC variations on Active Pharmaceutical Ingredients (API), Intermediates and Drug Product. Now, as a result of a significant growth in capabilities, the Global Regulatory Centre creates new role in the Product Variation area, Regulatory Project Manager, where leading submissions and its strategy aspect, acting as a Subject Matter Expert and Dossier Technical Approver will be one of the key aspects of this role. Role creates an opportunity to make a real, positive impact on GSK Patients worldwide, delivering CMC Projects and ensuring continuity of supply for life saving medicines. Our structures are growing, and we are currently looking for several successful candidates to join our teams. Your responsibilities: Driving regulatory strategy and taking responsibility for multiple complex CMC regulatory submissions: planning, coordination and execution, in order to support applications for marketing authorization, lifecycle activities and maintenance of registered products across Pharma, Vaccines and Biopharm portfolios, in accordance with the applicable regulatory and scientific standards, Identifying risks associated with submission data and information packages. Ensuring adequate contribution during interactions with senior stakeholders, Ensuring adequate interaction and partnership with the Global Regulatory Lead’s team, PSC, QA, LOCs, 3rd Parties in order to define proper regulatory CMC filing strategy. Building and maintaining good relationships with internal and external stakeholders, Acting as Technical Dossier Approver and performing complete data assessment to ensure that CMC submission content complies with internal regulatory processes and external requirements for European and International countries, Identifying improvement opportunities for CMC Regulatory processes, policies, instructions and systems followed by creation and implementation of working practices and procedures aimed at simplifying processes and increasing quality, Acting as dedicated expertise area SME (Subject Matter Expert), increasing capability within the CMC Regulatory teams and other impacted functions, by providing guidance and relevant knowledge while sharing best-practices, Working closely and providing CMC regulatory expert advice and guidance to R&D teams, QA, Pharma Supply Chain (PSC), Local Operating Companies (LOC) in markets worldwide. Basic qualifications: Medical or biological background - Master's degree or above in Pharmacy, Biotechnology, Biology, Chemistry/Biochemistry or other closely related medical/life science advanced degree, Strong experience in CMC Regulatory Affairs in pharmaceutical industry or research organization, Extensive expertise in regulatory strategy planning, dossier preparation (Module 1-3 CTD), dossier technical review and in all associated CMC regulatory aspects, Sound understanding of the pharmaceutical industry, drug development environment and regulatory processes, ICH guidelines and requirements, including EU regulatory procedures. Specialized area of expertise, Exceptional flexibility, analytical thinking and growth mindset, Excellent interpersonal skills; ability to communicate clearly and effectively, work in a diverse team and build strong relationships across a large organization, Fluent Polish and English speaking and writing skills. Preferred qualifications: Satisfactory French speaking and writing skills, Proven Project Management skills and high ability to handle and direct multiple projects/matrix teams, Negotiation and problem solving skills, Adapting to changing circumstances through priorities reassessment and a disciplined, logical work style. What we offer: Established job in an international, well-known pharmaceutical company, Possibilities to develop within the role and company’s structure, Opportunity to work in a professional team, playing crucial role in supporting GSK portfolio worldwide, Opportunity to work within GSK standards and documentation applied globally, Extensive support of work life balance (flexible working hours, remote work, health & wellbeing activities), Attractive reward package and wide range of benefits (annual bonus, awards for outstanding performance, Rewards and Recognition Programme, Medical Plan, Life Insurance, Employee Retirement Program, Sport and recreation cards, Recreation allowance), Employee Assistance Program (help in personal crises, return to work, diseases, psychological support etc.), Corporate culture based on our values: patient focus, integrity, respect and transparency, Environment focused on inclusion and diversity, Extensive learning programs.
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