Job Title: Regulatory Specialist

Job Purpose:

In this role, you will play a key part in delivering high‑quality CMC (Chemistry, Manufacturing and Controls) Annual Reports and associated regulatory activities for GSK’s global Pharma (Rx) and Vaccine (Vx) portfolio. You will work closely across GSK’s global regulatory network to prepare Annual Reports for NDAs (New Drug Applications), BLAs (Biologics License Applications), DMFs (Drug Master Files), Canadian Annual Notifications, as well as Brazil and China CMC Annual Reports. You will prepare technical documentation, ensure compliance with worldwide post‑approval requirements, and contribute your regulatory expertise to support the continued quality, safety, and availability of GSK products.

This position is a great opportunity to grow your regulatory career, strengthen your CMC knowledge, and contribute to improving processes and digital capability within the organization.

Key Responsibilities

• Take responsibility for the planning, preparation, technical review, and delivery of CMC Annual Reports for NDAs, BLAs, DMFs, Canadian Annual Notifications, and Brazil/China Annual Reports for GSK’s established Pharma and Vaccine product portfolio.

• Actively build relationships and maintain strong collaboration with internal and external stakeholders, including LOCs (Local Operating Companies), Product Owners, manufacturing sites, Submission Leads and Teams, and others.

• Contribute to the creation, improvement, and implementation of working practices aimed at simplifying processes and enhancing quality.

• Monitor regulatory intelligence and proactively act on changes to global regulatory requirements.

• Manage multiple submissions and projects simultaneously while maintaining accuracy, completeness, and timeliness.

• Identify opportunities for increased efficiency and drive improvements within the Annual Reporting processes.

• Support the development of digital fluency within the team and broader organization.

• Provide training or mentoring as needed.

Basic Qualifications:

• Bachelor’s degree in Life Sciences, Chemistry, Health Sciences, Pharmacy, or a related discipline.

• Minimum 2 years’ experience performing CMC regulatory activities.

• Experience in the pharmaceutical industry and regulatory affairs.

• Experience or knowledge of worldwide CMC post‑approval regulatory requirements.

• Fluent English, both written and spoken.

Preferred Qualifications:

• Experience with CTD/eCTD (Common Technical Document/ electronic Common Technical Document) documentation and global regulatory submissions/markets.

• Experience or understanding of drug development, manufacturing, or supply processes

Attributes:

• Organizational and analytical skills.

• Attention to detail with a focus on accuracy and completeness.

• Interpersonal skills and communication skills to effectively collaborate in a diverse global team environment and build relationships across a large organization.

Working Arrangement:

This role operates in a hybrid model based in Bengaluru, India.

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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