Job Description

Site Name:

Poznan Grunwaldzka, Bengaluru Luxor North Tower

Posted Date:

Oct 23 2025

As a Regulatory Project Manager in Regulatory Affairs Operations, you will be key in shaping and executing Chemistry, Manufacturing, and Controls (CMC) regulatory strategies to support marketing authorizations, lifecycle management, and maintenance of biopharmaceutical products. Your role will involve preparing and authoring complex technical regulatory dossiers, managing submission risks, and leading CMC regulatory discussions with global health authorities. You will also drive continuous improvement by enhancing CMC regulatory processes, policies, and systems while serving as a Subject Matter Expert and Technical Dossier Approver. As a mentor, you will help onboard and develop new team members, fostering a collaborative and high-performing environment. Success in this role relies on strong cross-functional collaboration with teams such as Global Regulatory Leads, GSC, MSAT, QA, LOCs, and ESQ to define and implement effective regulatory CMC filing strategies.

Key Responsibilities:

Independently assesses, manages, and/or drives the CMC strategy, coordinates, timely prepares, and authors multiple complex CMC technical regulatory documents to support applications for marketing authorisation, lifecycle activities and maintenance of registered products across Biopharm portfolio in accordance with the applicable regulatory and scientific standards, considering the evolving regulatory requirements. Understands internal and external Regulatory environment with the ability to provide guidance to R&D teams, Quality Control, GSC, QA and LOC. Ensures adequate interaction and partnership with Senior Stakeholders (Leadership Team) in order to define proper regulatory CMC filing strategy demonstrating flexible thinking and continuous improvement while maintaining customer focus. Ensures adequate contribution during interactions with Worldwide Regulatory Authorities. Authors responses to Regulatory Agency questions. Understands regulations, guidelines, procedures, and policies relating to registration and manufacturing of pharmaceutical products to expedite submission, review and approval of global applications while ensuring regulatory compliance is maintained and sharing best-practices and learnings within the CMC Regulatory teams and other impacted functions. May engage and lead CMC Subject Matter Expert activities. Mentors and/or trains staff, develop Subject matter experts (SMEs) within team by providing guidance and relevant knowledge. Identifies risks associated with submission data and information packages and can influence people, systems, processes, and formulate alternative approaches. Contributes to, and leads (as required) the creation, maintenance and continuous improvement of CMC Regulatory processes, work instructions, policies and systems. Ensures information submitted in marketing applications meets CMC and regional requirements and escalates to line manager, as applicable, risk or issues that have business impact. Communicates, through the appropriate teams, complex regulatory issues across GSK and with external agencies and third parties as necessary to influence CMC project and policy issues that are aligned with GSK business needs ensuring optimum position for GSK. May represent GSK externally (e.g. Audits, Conferences, External Forums).


Basic Qualifications:

Around 6-7 years of experience Sound knowledge and understanding of drug development and manufacturing and supply processes and may have a specialized area of expertise. Demonstrated ability to handle complex global CMC submissions and issues through continuous change and improvement. Detailed working knowledge of complex worldwide CMC regulatory requirements and demonstrated ability to influence the global internal/external regulatory environment. Proven project management and multi-tasking skills. High ability to manage matrix teams and direct multiple projects. Experience in influencing and negotiating with GSK personnel in a variety of settings.


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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.


GSK is an Equal Opportunity Employer. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), parental status, national origin, age, disability, genetic information (including family medical history), military service or any basis prohibited under federal, state or local law.

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