Senior Regulatory Specialist

Business Introduction At GSK, we have bold ambitions for patients, aiming to positively impact the health of 2.5 billion people by the end of the decade. Our R&D focuses on discovering and delivering vaccines and medicines, combining our understanding of the immune system with cutting-edge technology to transform people’s lives. GSK fosters a culture ambitious for patients, accountable for impact, and committed to doing the right thing, making sure that we focus our efforts on accelerating significant assets that meet patients’ needs and have the highest probability of success. We’re uniting science, technology, and talent to get ahead of disease together. Find out more: Our approach to R&D Position Summary • Represents CMC Delivery team on Regulatory Networks and Matrix Teams providing guidance to Pharma Supply Chain (PSC), Commercial, Quality Assurance, 3 rd Party Contract Manufacturing Organizations and Office of the Chief Medical Officer (OCMO) to produce appropriate components for global regulatory dossiers. • Role requires a general understanding of submission requirements for multiple countries/ submission types and an ability to work in a matrix environment. Responsible for timely delivery of regulatory activities of multiple Vx projects across dosage forms • Will serve as a mentor/trainer for new team members.  • May act as a Subject Matter Expert for specific areas for consultation within     the team/ department as well as externally outside the department. Responsibilities • Independently manages multiple Vx CMC regulatory submission assignments simultaneously; assignments will range in complexity, but more complex work is expected. • Independently and confidently executes agreed dossier strategy. • Independently completes data assessment to ensure dossier is fit for purpose. • Identifies risks associated with submission data and information packages. • Escalates issues with line manager that have business impact. • May act as reviewer/approver for dossiers prepared by peers and identifies improvement opportunities for Regulatory processes, policies and systems. • Understands regulations, guidelines, procedures and policies relating to registration and manufacturing of pharmaceutical products, to expedite submission, review and approval of global applications. May provide consultation and solutions being the subject matter expert in specific areas of expertise. Acts as mentor/trainer for new staff. • Understands internal/external Regulatory environment. • Actively builds an organisational network (PSC, LOC, PO and other relevant stakeholders), promotes and is engaged in knowledge and experience sharing. • Communicates across GSK, as necessary regarding project and policy issues ensuring optimum position for GSK. Preferred Qualification • Working in complex environment within a scientific organization Minimum 3-8 years of experience • Bachelor’s degree.( Chemistry, pharmacy or other related science or technical bachelor’s degree. • Broad understanding of the pharmaceutical industry, drug development environment, and R&D processes and objectives. • Global/ EMAP Regulatory submission experience - Knowledge of regulatory agency guidelines • Excellent organisational skills, attention to detail and commitment to deliver high quality output, even under pressures sometimes demanded by regulatory deadlines • Excellent written and verbal communication skills and ability to present information in a clear and concise manner • Ability to interpret and advise on guidelines and requirements on a global basis, reflecting recent GSK experience • Ability to build effective working relationships and work in a matrix environment effectively • Ability to think flexibly in order to meet constantly shifting priorit