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GSK Logo GSK · IT - Administration

Senior Regulatory Specialist

India, Bengaluru Employment contract 144750.00 - 241250.00 PLN / Year · Job Posted May 30, 2026
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Job Description

At GSK, we unite science, technology, and talent to get ahead of disease together. Our goal is to improve the lives of billions across the world. By bringing together outstanding people in an inclusive environment, we can make an impact on a global scale.

Job Responsibility

  • Responsible for the timely delivery of regulatory activities of multiple projects across dosage forms
  • Represents New Registration CMC, on Regulatory Networks and Matrix Teams providing guidance to Global Supply Chain (GSC), Commercial, Quality Assurance, 3rd Party Contract Management (via ESQ) 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
  • Independently and confidently executes agreed dossier strategy
  • Independently manages multiple project 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
  • Serves as dossier reviewer for 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 (GSC, LOC, PO, team members 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

Requirements

  • Bachelor's degree in Chemistry, pharmacy or other related biological science or technical bachelor's degree
  • English language skills
  • Knowledge of drug development and manufacturing and supply processes
  • Knowledge of worldwide CMC post-approval regulatory requirements
  • Can identify areas for personal professional growth in global regulatory affairs with appropriate support from line manager
  • Service orientation, customer-focused

What we offer

  • Competitive base salary
  • Annual bonus based on company performance
  • Flexible working options available for most roles
  • Learning and career development
  • Access to healthcare & wellbeing programmes
  • Employee recognition programmes
  • Annual bonus
  • Eligibility to participate in our share based long term incentive program
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