Regulatory Associate Manager

Job Title: 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.
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 collaborate with cross-functional teams, including supply chain, quality assurance, and commercial teams, to support global regulatory submissions. We are looking for candidates who are detail-oriented, proactive, and committed to delivering high-quality results. This is an opportunity to make a meaningful impact while growing your career in a supportive 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**
We are seeking professionals with the following required skills and qualifications to help us achieve our goals:
- Bachelor's degree in chemistry, pharmacy, or a related science or technical field.
- Minimum of 5 years of experience in regulatory affairs, specifically in CMC (Chemistry, Manufacturing, and Controls).
- Proven ability to manage multiple projects simultaneously, including complex assignments.
- Strong understanding of global regulatory guidelines and requirements.
- Excellent organizational skills and attention to detail, with a commitment to delivering high-quality outputs.
- Effective written and verbal communication skills, with the ability to present information clearly and concisely.

**Preferred Qualification**
If you have the following characteristics, it would be a plus:
- Broad understanding of the pharmaceutical industry and drug development processes.
- Experience with global regulatory submissions and knowledge of regulatory agency guidelines.
- Ability to interpret and advise on regulatory requirements across different regions.
- Strong interpersonal skills and ability to build effective working relationships in a matrix environment.
- Flexibility to adapt to shifting priorities and timelines while maintaining focus on deliverables.
- Experience mentoring or training team members to build organizational capability.

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.

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