GSK hiring Regulatory Project Manager - Vacancy for Advanced degree in Pharmacy, Biotechnology, Biology, Chemistry/Biochemistry

GSK is a global biopharma company with a special purpose – to unite science, technology and talent to get ahead of disease together – so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns – as an organisation where people can thrive. Getting ahead means preventing disease as well as treating it, and we aim to impact the health of 2.5 billion people around the world in the next 10 years.

Post : Regulatory Project Manager

Job Description
Role purpose
The CMC Mature Vx Delivery Lead plays a critical role in supporting registered vaccines products by managing complex CMC submissions (such as CMC Post-approval variations, Health Authorities consultations or responses to Health Authorities questions). This includes addressing regulatory requirements for Active Pharmaceutical Ingredients, Intermediates, and Drug Products across global markets. Through his/her expertise in CMC regulatory requirements and dossiers preparation, the CMC Mature Vx Delivery Lead is ensuring the quality and accuracy of CMC-related information.

The role of Regulatory Project Manager (Delivery Lead) creates an opportunity to lead initiatives that drive efficiency and innovation, ensuring continuity of supply for life-saving medicines and making a tangible difference for patients.

You will take on a key role in ensuring the timely and efficient delivery of regulatory activities across multiple CMC projects within the Vx business. You will collaborate cross-functionally with diverse teams within the Global Regulatory Organization, Global Supply Chain, Quality Assurance, Contract Manufacturing Organizations to contribute to the development of high-quality components for global regulatory dossiers. Additionally, you will have the opportunity to mentor and guide new team members, fostering their growth and driving the success of the team.

As a Regulatory Project Manager (Delivery Lead), you will :
• Take ownership for multiple complex CMC regulatory submissions, including planning, coordination and execution, to support applications for marketing authorizations, lifecycle activities and maintenance of registered products across Vaccines portfolio, in accordance with the applicable regulatory and scientific standards.
• Manage multiple project assignments simultaneously, including CMC variations and handling Health Authority Questions (HAQs) for Finished Products, Intermediates, and Active Pharmaceutical Ingredients for Vaccines products (i.e. largely involving updates to the CTD Module 3, Quality section of the dossiers).
• Identify risks associated with submission data and information package; and support the development of mitigation strategies.
• Collaborate closely with cross-functional teams, such as Global Regulatory Lead’s team, Global Supply Chain (GSC), Quality Assurance (QA), Local Operating Companies (LOCs), and third Parties to build regulatory CMC submissions and maintain strong relationships, including with senior stakeholders.
• Identify improvement opportunities for CMC Regulatory processes, policies, instructions and systems, developing and implementing simplified working practices and procedures to enhance efficiency and quality.
• Serve as Subject Matter Expert (SME) for CMC Regulatory Affairs, mentoring and guiding team members, while sharing best practices to build capability and knowledge within the CMC Regulatory teams and other impacted functions.

Candidate Profile
• Advanced degree (Master's or above) in Pharmacy, Biotechnology, Biology, Chemistry/Biochemistry or other closely related medical/life science field.
• Strong experience in CMC Regulatory Affairs within pharmaceutical industry or research organization.
• Extensive expertise in regulatory strategy planning, dossier preparation (CTD Module 1-3), technical dossier review and in all associated CMC regulatory aspects.
• Sound understanding of the pharmaceutical industry, drug development environment, regulatory processes and ICH guidelines and requirements, including EU regulatory framework.
• Exceptional flexibility, analytical thinking and growth mindset
• Excellent interpersonal skills; including clear and effective written and verbal communication, and the ability to build strong relationships across a diverse, large organization
• English writing skills
• Excellent organizational skills, ability to handle multiple tasks, prioritize effectively and deliver high quality output under imposed deadlines, with a strong attention to detail (with emphasis on accuracy and completeness).

Additional Information
Location : Bengaluru, India
Industry Type : Pharma/ Healthcare/ Clinical research
Categories : Regulatory
Req ID : 433514
End Date : 10th February 2026