Manager- Global Regulatory Affairs CMC

gsknch; Andhra Pradesh; On-site; INR 1,500,000 - 2,100,000; Full time

Job summary

Haleon in Hyderabad is seeking a Regulatory Affairs CMC Manager to execute regulatory activities for new product registrations and lifecycle maintenance across a defined portfolio. You will prepare CMC sections and coordinate with global teams to ensure timely, compliant submissions.

The role requires 5–6+ years in Regulatory Affairs with a strong grounding in Quality, product development, and manufacturing, and the ability to navigate complex regulatory environments.

Qualifications

• Specialisation in Life science/Pharmaceutically-related science.
• 5 to 6 plus years' experience in Regulatory Affairs.
• Knowledge in Quality, product development and manufacturing.

Responsibilities

• Responsible for CMC regulatory matters relating to registrations and/or life-cycle maintenance of business activities (including variations and renewals) for assigned product portfolio.
• Preparation of CMC sections of new registration files, PIFs, MDTFs, briefing books, clinical trials applications/INDs, CMC variations, responses to Regulatory Agency technical questions.
• Interacts with colleagues in other global functions to deliver high quality CMC sections for dossiers, PIFS or MDTFs including documents & materials to local Regulatory Affairs in accordance with business priorities.
• Applies processes and procedures to maintain up-to-date technical product records/information and support adequate controls.
• Provides CMC evaluations for potential changes as requested and follows up to ensure regulatory compliance including completion of appropriate internal compliance records.

Skills

Regulatory affairs

Quality knowledge

Product development

Manufacturing knowledge

Education

B Pharm

B Sc

M Pharm

MBA

PhD/PharmD

Job description

Welcome to Haleon. We're a purpose-driven, world-class consumer company putting everyday health in the hands of millions. In just three years since our launch, we've grown, evolved and are now entering an exciting new chapter - one filled with bold ambitions and enormous opportunity.

Our trusted portfolio of brands - including Sensodyne®, Panadol®, Advil®, Voltaren®, Theraflu®, Otrivin®, and Centrum® - lead in resilient and growing categories. What sets us apart is our unique blend of deep human understanding and trusted science.

Now it's time to fully realise the full potential of our business and our people. We do this through our Win as One strategy. It puts our purpose - to deliver better everyday health with humanity - at the heart of everything we do. It unites us, inspires us, and challenges us to be better every day, driven by our agile, performance-focused culture.

Hello. We're Haleon . A new world-leading consumer health company. Shaped by all who join us. Together, we're improving everyday health for billions of people. By growing and innovating our global portfolio of category-leading brands - including Sensodyne, Panadol, Advil, Voltaren, Theraflu, Otrivin, and Centrum - through a unique combination of deep human understanding and trusted science. What's more, we're achieving it in a company that we're in control of. In an environment that we're co-creating. And a culture that's uniquely ours. Care to join us. It isn't a question.

With category leading brands such as Sensodyne, Voltaren and Centrum, built on trusted science and human understanding, and combined with our passion, knowledge and expertise, we're uniquely placed to do this and to grow a strong, successful business.

This is an exciting time to join us and help shape the future. It's an opportunity to be part of something special.

About the role

Regulatory Affairs CMC Manager

The purpose of this role is to execute CMC regulatory activities for new products registrations and life-cycle maintenance (including variations and renewals) for a defined portfolio of products.

Role Responsibilities

• Responsible for CMC regulatory matters relating to registrations and/or life-cycle maintenance of business activities (including variations and renewals) for assigned product portfolio. Preparation of CMC sections of new registration files, PIFs, MDTFs, briefing books, clinical trials applications/INDs, CMC variations, responses to Regulatory Agency technical questions.
• Interacts with colleagues in other global functions (e.g. Category, BU, Quality and Supply Chain) to deliver high quality CMC sections for dossiers, PIFS or MDTFs including documents & materials to local Regulatory Affairs in accordance with business priorities. Ensures close partnership with authors, assuring technical congruency and regulatory compliance.
• Applies processes and procedures to maintain up-to-date technical product records/information and support adequate controls.
• Provides CMC evaluations for potential changes as requested and follows up to ensure regulatory compliance including completion of appropriate internal compliance records e.g. change controls.
• Effectively communicates regulatory technical requirements and guidelines, facilitating timely and complete submissions. Develops up-to-date knowledge with regard to technical guidelines and regulatory requirements, as well as technical trends.

Basic Qualifications

• Specialisation in Life science/Pharmaceutically-related science (Chemistry, Pharmacy, Biochemistry, Biology, Medical Engineering)
• 5 to 6 plus years' experience in Regulatory Affairs.
• Knowledge in Quality, product development and manufacturing

Preferred Qualifications

• B Pharm or B Sc', 'M Pharm, Masters (MBA , MS, MA), or PhD/PharmD/JD QP

Location - this role is based in: Hyderabad

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Diversity, Equity and Inclusion

At Haleon we embrace our diverse workforce by creating an inclusive environment that celebrates our unique perspectives, generates curiosity to create unmatched understanding of each other, and promotes fair and equitable outcomes for everyone.

We're striving to create a climate where we celebrate our diversity in all forms by treating each other with respect, listening to different viewpoints, supporting our communities, and creating a workplace where your authentic self belongs and thrives.

We believe in an agile working culture for all our roles. If flexibility is important to you, we encourage you to explore with our hiring team what the opportunities are.

Job Posting End Date

2026-11-05

Equal Opportunities

Haleon are committed to mobilising our purpose in a way that represents the diverse consumers and communities who rely on our brands every day. It guides us in creating an inclusive culture, where different backgrounds and views are valued and respected - all in support of understanding and best serving the needs o