Job Title: Regulatory Specialist - MSR Coordination 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.
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Our approach to R&D Position Summary You will coordinate Master Submission Record (MSR) activities that support regulatory submissions and product lifecycle needs. You will work closely with global and local regulatory teams, suppliers, quality and manufacturing partners. We value clear communicators who are organised, curious and committed to continuous improvement. This role offers visible impact, opportunities to learn regulatory systems, and alignment with GSK’s mission of uniting science, technology and talent to get ahead of disease together. This role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities include some of the following: - Coordinate collection, assessment and tracking of MSR documentation from suppliers, manufacturing, quality and local offices to meet submission timelines. - Prepare, review and assemble MSR packages for variations, renewals, product expansions and regional projects. - Identify data gaps, quality issues or risks and drive resolution with internal and external stakeholders. - Maintain accurate records in regulatory information systems and perform routine data quality checks. - Support system activities such as basic user support, user acceptance testing and document control tasks. - Contribute to process improvements, standard work instructions and knowledge sharing across regulatory teams. Responsibilities - Execute agreed MSR strategy for assigned dossiers with minimal supervision. - Liaise with suppliers and internal partners to obtain required documents on time. - Assess MSR packages for completeness and fit-for-purpose prior to submission. - Prepare clear status updates and escalate issues that may affect delivery or compliance. - Support production of routine and ad-hoc reports and data extracts for stakeholders. - Share knowledge and review or mentor colleagues as needed to improve team performance. Why You? Basic Qualification We are seeking professionals with the following required skills and qualifications to help us achieve our goals: - Bachelor’s degree in life sciences, pharmacy, chemistry or a related field. - Minimum 3 years of experience in regulatory affairs, regulatory operations, submissions or regulatory document management. - Experience managing dossier documentation, record keeping or Master Submission Records. - Familiarity with regulatory and manufacturing documentation requirements in a regulated environment. - Proficiency with MS Office tools and experience with collaboration platforms such as SharePoint. - Strong written and verbal communication skills in English and ability to work with global teams. Preferred Qualification If you have the following characteristics, it would be a plus: - Experience with Regulatory Information Management Systems (RIMS) or content management systems such as Veeva Vault. - Experience with eCTD and non-eCTD submission processes and publishing tools. - Practical knowledge of quality, supply chain or manufacturing interfaces in regulated environments. - Experience performing data quality checks, root cause analysis or trend analysis. - Experience supporting user acceptance testing or basic system administration tasks. - Master’s degree or professional certification in regulatory affairs or related field. Working Model This role is on-site in India with occasional hybrid flexibility subject to business needs. You will regularly interact with global colleagues and local stakeholders across time zones. What you can expect You will join a supportive team focused on learning and meaningful impact. You will gain hands-on experience across regulatory operations and systems. You will have opportunities to grow your skills and take on wider responsibilities. We encourage you to apply if this role aligns with your experience and career goals. If you need adjustments during the recruitment process, please tell us so we can support you. Apply now to help move important regulatory work forward.

Why GSK?

Uniting science, technology and talent to get ahead of disease together.

GSK is a global biopharma company with a purpose to unite science, technology and talent to get ahead of disease together. We aim to positively impact the health of 2.5 billion people by the end of the decade, as a successful, growing company where people can thrive. We get ahead of disease by preventing and treating it with innovation in specialty medicines and vaccines. We focus on four therapeutic areas: respiratory, immunology and inflammation; oncology; HIV; and infectious diseases – to impact health at scale.

People and patients around the world count on the medicines and vaccines we make, so we’re committed to creating an environment where our people can thrive and focus on what matters most. Our culture of being ambitious for patients, accountable for impact and doing the right thing is the foundation for how, together, we deliver for patients, shareholders and our people.

Inclusion at GSK:

As an employer committed to Inclusion, we encourage you to reach out if you need any adjustments during the recruitment process.

Please contact our Recruitment Team at [email protected] to discuss your needs.

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