Regulatory Associate Manager - Product Variations, CD CMC

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 lead regulatory work for product variations within Clinical Development CMC. You will work with colleagues across supply chain, quality, clinical teams and external partners. We value clear thinking, practical problem solving and a focus on quality. This role offers growth through exposure to global submissions and complex projects. You will make a real impact on patient health by helping bring safe and compliant products to market. Responsibilities This role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities include some of the following: - Manage regulatory activities for product variations from planning to submission and approval. - Prepare, review and approve CMC components of regulatory dossiers for global submissions. - Assess data and documentation to confirm they are complete, compliant and fit for purpose. - Identify regulatory risks and raise clear, timely escalations with mitigation options. - Work closely with supply chain, quality, clinical and external manufacturers to gather and align submission data. - Share knowledge, coach colleagues and contribute to improving regulatory processes and tools. Why You? This role is on-site in India with opportunities to collaborate with global teams. We welcome applicants from diverse backgrounds. You will join a supportive, high-impact team that values learning and career development. If you want to grow your expertise in regulatory CMC and contribute to meaningful work for patients, we encourage you to apply. Basic Qualification We are seeking professionals with the following required skills and qualifications to help us achieve our goals: - Bachelor’s degree in chemistry, pharmacy, pharmaceutical sciences or a related science/technical field. - Minimum 5 years of regulatory affairs experience with a focus on CMC and product variations. - Experience preparing or managing CMC dossiers for regulatory submissions. - Knowledge of global regulatory guidelines and expectations for CMC content. - Strong organisational skills and experience managing multiple projects and deadlines. - Good written and verbal communication skills in English for clear, concise dossier writing and stakeholder engagement. Preferred Qualification If you have the following characteristics, it would be a plus: - 6 to 10 years’ experience in pharmaceutical regulatory CMC, including global submissions. - Prior experience working with contract manufacturing organisations and supply chain partners. - Experience acting as dossier reviewer or approver. - Ability to interpret and advise on regional regulatory requirements. - Experience mentoring or training junior staff and building capability. - Comfortable working in a matrix environment with cross-functional teams. How to apply We want to hear from you. If this role fits your experience and ambitions, please apply now. Include your CV and a short note about why you want to join our team.

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:

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