Regulatory Associate Manager- CMC variations, Small molecules

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.
Find out more:
Our approach to R&D

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. We value individuals who are detail-oriented, proactive, and committed to delivering high-quality results. This is an opportunity to make a meaningful impact while advancing your career in a collaborative and inclusive environment.

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 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 Qualification

• Managing multiple project assignments simultaneously, including CMC variations, source transfers, and handling Health Authority Questions (HAQs) for Finished Products, Intermediates, and Active Pharmaceutical Ingredients for Pharma products (working with the CTD Module 3, Quality section of the dossiers).

• Managing assigned projects by executing agreed dossier strategies, completing data assessments to ensure dossiers are fit for purpose and in compliance with GSK regulatory processes and external requirements for local markets (e.g., Europe, US, and International countries), and 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 the Global Supply Chain, Global Regulatory Groups, and GSK Local Operating Companies in markets 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 Qualification

• Bachelor's or Master's degree in biotechnology, chemical technology, pharmacy, chemistry, or another related science or technical field.

• Relevant experience  in regulatory affairs (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

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.
Find out more:
Our approach to R&D

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. We value individuals who are detail-oriented, proactive, and committed to delivering high-quality results. This is an opportunity to make a meaningful impact while advancing your career in a collaborative and inclusive environment.

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 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 Qualification

• Managing multiple project assignments simultaneously, including CMC variations, source transfers, and handling Health Authority Questions (HAQs) for Finished Products, Intermediates, and Active Pharmaceutical Ingredients for Pharma products (working with the CTD Module 3, Quality section of the dossiers).

• Managing assigned projects by executing agreed dossier strategies, completing data assessments to ensure dossiers are fit for purpose and in compliance with GSK regulatory processes and external requirements for local markets (e.g., Europe, US, and International countries), and 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 the Global Supply Chain, Global Regulatory Groups, and GSK Local Operating Companies in markets 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 Qualification

• Bachelor's or Master's degree in biotechnology, chemical technology, pharmacy, chemistry, or another related science or technical field.

• Relevant experience  in regulatory affairs (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

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 IN.recruitment- to discuss your needs.

Important notice to Employment businesses/ Agencies

GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site.

It has come to our attention that the names of GlaxoSmithKline or GSK or our group companies are being used in connection with bogus job advertisements or through unsolicited emails asking candidates to make some payments for recruitment opportunities and interview. Please be advised that such advertisements and emails are not connected with the GlaxoSmithKline group in any way.

GlaxoSmithKline does not charge any fee whatsoever for recruitment process. Please do not make payments to any individuals / entities in connection with recruitment with any GlaxoSmithKline (or GSK) group company at any worldwide location. Even if they claim that the money is refundable.

If you come across unsolicited email from email addresses not ending in or job advertisements which state that you should contact an email address that does not end in "", you should disregard the same and inform us by emailing , so that we can confirm to you if the job is genuine.