RA Senior Manager OH Category

Haleon; Telangana; On-site; INR 3,000,000 - 5,000,000; Full time

Job summary

Haleon seeks a senior regulatory professional to manage regulatory governance for a product portfolio globally. You will partner with R&D, supply chain and commercial teams to ensure compliance and timely approvals across lifecycle activities.

You may lead a small team, set vision for sub-category strategy, and deliver high-quality regulatory files within deadlines to support Haleon’s portfolio and market access objectives.

Qualifications

• 10+ years of experience in regulatory affairs or related field.
• Bachelor’s degree in science Life science, Consumer Healthcare, or pharma-related science.
• Skilled in interpretation, evaluation and communication of technical information to R&D, supply chain and commercial teams.
• Ability to handle multiple projects and tasks simultaneously with attention to detail.
• Knowledge of regulatory pathways, strategic thinking and external negotiations.

Responsibilities

• Acts as regulatory advisor across brands or product subset for drug/cosmetic/devices/food depending on category.
• Prepare CMC sections, briefing books and regulatory submissions for filings.
• Develop regulatory strategies to secure timely approvals and lifecycle maintenance.
• Provide CMC evaluations and ensure internal compliance records are completed.
• Communicate regulatory requirements clearly to cross-functional teams and stakeholders.
• Mentor team members and deliver high-quality regulatory files on schedule.
• Support policy improvements and cross-functional inputs for new processes.

Skills

Regulatory strategy

Cross-functional collaboration

Data analysis

Technical writing

Regulatory affairs

Education

Life science degree

Pharmaceutical/science degree

Regulatory Affairs education

Job description

About the Role

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

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. During the application process, we may ask you to share some personal information, which is entirely voluntary. This information ensures we meet certain regulatory and reporting obligations and supports the development, refinement, and execution of our inclusion and belonging programmes that are open to all Haleon employees. The personal information you provide will be kept confidential, used only for legitimate business purposes, and will never be used in making any employment decisions, including hiring decisions.

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.

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.