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.

Why you

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 qualified at this level must be skilled in scientific interpretation / evaluation / communication of technical information and an ability to interface effectively with RD, 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

Disclaimer : This job posting has been aggregated from external source. Role details, content, and availability are subject to change. Applicants are advised to confirm the latest information directly on the company website before applying.

📌 RA Senior Manager OH Category (Hyderabad)
🏢 Haleon
📍 Hyderabad