RA Senior Manager OH Category

Haleon; Lucknow; On-site; INR 3,000,000 - 6,000,000; Full time

Job summary

Haleon is seeking a senior Regulatory Affairs professional to lead regulatory management for a portfolio of products, ensuring global compliance across lifecycle activities. You will build partnerships with R&D, supply chain and commercial teams and provide specialist regulatory guidance while potentially mentoring junior staff.

The role emphasizes strategic regulatory thinking, data-driven decision making and delivering high-quality regulatory files on time, with involvement in cross-functional

Qualifications

• 10+ years of experience in regulatory affairs or related field.
• Bachelor’s degree in science or related field.
• Life science, Consumer Healthcare, Pharmaceutically-related science, R&D or Regulatory Affairs.
• Regulatory professional at this level must be skilled in scientific interpretation/evaluation/communication of technical information and an ability to interface effectively with R&D, supply chain and commercial counterparts with credibility.
• Ability to work on multiple projects or tasks simultaneously; ability to analyse data and write reports with attention to detail.
• Ability to use regulatory knowledge; use strategic regulatory thinking; ability to plan and organize regulatory pathways and critically evaluate and report.

Responsibilities

• Acts as a Business Partner and provides regulatory advice across a brand or subset of products on aspects of drug/cosmetic/devices/food and supplements (dependent on category) development and regulatory requirements as appropriate, and/or responsible for regulatory matters relating to life-cycle maintenance of business activities (including variations and renewals) for assigned product portfolio. Preparation of CMC sections of new medicinal registration files, PIFs, MDTFs, TMACs briefing books, clinical trials applications/INDs, Variations, responses to Regulatory Agency technical questions
• Develops novel regulatory strategies and influences approaches within Project Teams in order to secure competitive approvals and speed to market in conjunction with LOC/BU/Region regulatory teams.
• 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. Within Regulatory at all levels and within cross-functional Project Teams
• May supervise or mentor other team members.
• Plans, prepares and delivers high-quality regulatory files to agreed timelines.
• May lead non-product related activities within the function and input cross functionally, in order to direct new policy or pioneer new processes or improvements to company's competitive advantage.
• Support the development of the strongest claims possible aligned to consumer insight and within the regulations, ensuring risks are appropriately addressed and communicated within the CAP meetings and tools.
• Ensures compliance of their actions by adhering to global, regional and local processes, policies, SOPs and working instructions.

Skills

Regulatory expertise

Scientific interpretation

R&D interfacing

Data analysis

Report writing

Project management

Education

Bachelor’s degree in science

Life science/Regulatory Affairs background

Job description

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.

About the Role

The purpose of this role is to provide regulatory management, governance and expertise to one category, sub-category, brand or a portfolio of products such that our products are successfully introduced or maintained Globally. The individual will build a network of collaborative relationships within Oral Health and LOC/BU/Region and ensure all regulatory requirements are met for both innovation and the lifecycle of existing products according to the company Values. An individual may also manage a small team for which they will set a compelling vision and deliver against the sub-category strategy and mission. The role requires the individual to provide specialist regulatory advice across the Category and Function.

Key Responsibilities

• Acts as a Business Partner and provides regulatory advice across a brand or subset of products on aspects of drug / cosmetic / devices / food and supplements (dependent on category) development and regulatory requirements as appropriate, and/or responsible for regulatory matters relating to life-cycle maintenance of business activities (including variations and renewals) for assigned product portfolio. Preparation of CMC sections of new medicinal registration files, PIFs, MDTFs, TMACs briefing books, clinical trials applications/INDs, Variations, responses to Regulatory Agency technical questions
• Develops novel regulatory strategies and influences approaches within Project Teams in order to secure competitive approvals and speed to market in conjunction with LOC/BU/Region regulatory teams.
• 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. Within Regulatory at all levels and within cross-functional Project Teams
• May supervise or mentor other team members.
• Plans, prepares and delivers high-quality regulatory files to agreed timelines.
• May lead non-product related activities within the function and input cross functionally, in order to direct new policy or pioneer new processes or improvements to company's competitive advantage.
• Support the development of the strongest claims possible aligned to consumer insight and within the regulations, ensuring risks are appropriately addressed and communicated within the CAP meetings and tools.
• Ensures compliance of their actions by adhering to global, regional and local processes, policies, SOPs and working instructions.

Basic Qualification

• 10+ years of experience
• Bachelor’s degree in science
• Life science, or Consumer Healthcare, or Pharmaceutically-related science, or Research and Development, or Regulatory Affairs
• Regulatory professional at this level must be skilled in scientific interpretation/evaluation/communication of technical information and an ability to interface effectively with R&D, supply chain and commercial counterparts with credibility
• Ability to work on multiple projects or tasks simultaneously. Ability to analyse data and write reports with attention to detail.
• Ability to use regulatory knowledge; use strategic regulatory thinking; ability to plan and organize regulatory pathways and critically evaluate and report.
• Working towards scientific knowledge; communication and influencing on route to market and external influencing and negotiating

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 of our consumers and unleashing the full potential of our people. It’s important to us that Haleon is a place where all our employees feel they truly belong.

Adjustment or Accommodations Request

If you require a reasonable adjustment or accommodation or other assistance to apply for a job at Haleon at any stage of the application process, please let your recruiter know by providing them with a description of specific adjustments you are requesting. We’ll provide all reasonable adjustments to support you throughout the recruitment process and treat all information you provide us in confidence.

Note to candidates

The Haleon recruitment team will contact you using a Haleon email account (@haleon.com). If you are not sure whether the email you received is from Haleon, please get in touch.