Regulatory Associate Manager – CMC variations, Small molecules

Location: Bengaluru Luxor North Tower, Poznan Grunwaldzka

Posted: Nov 6 2025

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. We foster a culture that is ambitious for patients, accountable for impact, and committed to doing the right thing, ensuring that we accelerate the most promising assets that meet patients’ needs and have the highest probability of success.

Position Summary

In this role, you will lead regulatory activities for product variations, ensuring compliance and quality across multiple projects. You will work closely with cross‑functional teams, including supply chain, quality assurance, and commercial teams, to support global regulatory submissions. The role requires a detail‑oriented, proactive, and collaborative professional who can deliver high‑quality results and make a meaningful impact.

Responsibilities

• Manage regulatory activities for product variations across multiple projects, ensuring timely delivery and compliance.
• Collaborate with internal and external stakeholders to produce high‑quality components for global regulatory dossiers.
• Assess data to ensure submissions are fit for purpose and identify risks associated with submission packages.
• Act as a reviewer or approver for regulatory dossiers prepared by peers, driving process improvements.
• Provide guidance on regulatory requirements, policies, and procedures to expedite submission and approval processes.
• Build effective networks within the organization to share knowledge and promote best practices.

Basic Qualifications

• Managing multiple project assignments simultaneously, including CMC variations, source transfers, and handling Health Authority Questions (HAQs) for finished products, intermediates, and active pharmaceutical ingredients.
• Executing agreed dossier strategies, completing data assessments to ensure dossiers are fit for purpose and comply with GSK regulatory processes and external requirements for local markets (e.g., Europe, US, and other countries), while identifying risks associated with submission data and information packages.
• Preparing and coordinating the review and approval of submission‑ready documents.
• Collaborating with Product Owners/Project Managers to provide regulatory support for assigned projects.
• Working with colleagues in Global Supply Chain, Global Regulatory Groups, and GSK Local Operating Companies worldwide to deliver high‑quality dossiers on time.
• Building and maintaining strong relationships with internal and external stakeholders.
• Monitoring regulatory intelligence and proactively acting on identified changes to regulatory requirements.
• Identifying improvement opportunities for CMC regulatory processes, policies, and systems.

Preferred Qualifications

• Bachelor’s or Master’s degree in biotechnology, chemical technology, pharmacy, chemistry, or another related science or technical field.
• Relevant experience in regulatory affairs within the pharmaceutical industry, with familiarity in post‑approval CMC regulatory procedures and ICH CTD documentation (Modules 2 and 3).
• Understanding of the pharmaceutical industry, drug development environment, and regulatory processes.
• Thorough understanding of change management processes and regulatory requirements.
• Attention to detail with an emphasis on accuracy and completeness.
• Ability to handle multiple tasks, meet shifting priorities, and schedule work to meet business needs.
• Flexible and analytical thinking to independently provide solutions to issues.
• Excellent interpersonal skills, including the ability to communicate clearly and effectively, work in a diverse team environment, and build relationships across a large organization.
• Excellent written and verbal communication skills in English.

This role is based in India and will require on‑site work, with opportunities for collaboration across global teams. If you’re ready to take the next step in your career and contribute to a mission‑driven organization, we encourage you to apply today!