Job Description

Site Name: Bengaluru Luxor North Tower Posted Date: Mar 6 2024 Job Purpose : Responsible for timely delivery of regulatory activities of multiple Rx and/or Vx projects across dosage forms. Represents CD on Regulatory Networks and Matrix Teams providing guidance to Pharma Supply Chain (PSC), Commercial, Quality Assurance, 3rd Party Contract Manufacturing Organizations and Office of the Chief Medical Officer (OCMO) to produce appropriate components for global regulatory dossiers. 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. Key Responsibilities : Independently and confidently executes agreed dossier strategy. Independently manages multiple Rx and/or Vx project assignments simultaneously; assignments will range in complexity, but more complex work is expected. 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. Job-Related Experience: Minimum 6-10 years of experience 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 priorities and timelines. Why Us GSK is a global biopharma company with a special purpose - to unite science, technology and talent to get ahead of disease together - so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns - as an organization where people can thrive. Getting ahead means preventing disease as well as treating it, and we aim to positively impact the health of 2.5 billion people by the end of 2030. Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it\'s also about making GSK a place where people can thrive. We want GSK to be a workplace where everyone can feel a sense of belonging and thrive as set out in our Equal and Inclusive Treatment of Employees policy. We\'re committed to being more proactive at all levels so that our workforce reflects the communities we work and hire in, and our GSK leadership reflects our GSK workforce. 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