Regulatory Affairs OTC Category Manager

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 the sub-category and LOC / BU / Region and ensure all regulatory requirements are met for both innovation and 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 may require 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.
• 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.
• Communicates effectively within the function 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.
• May act as company representative to external groups on specific task forces within their field of expertise.
• 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.
• In conjunction with the category regulatory CMC lead, ensure support for the full life cycle of products, including : maintenance activities;

Design to Value, complexity reduction, value engineering initiatives; change controls, etc. with supply chain and technical excellence.

Ensures compliance of their actions by adhering to global, regional and local processes, policies, SOPs and working instructions.

Knowledge / Education / Previous Experience Required

• BA or BSc in Life science / Pharmaceutically-related science (Chemistry, Pharmacy, Biochemistry, Biology, Medical Engineering)
• Position requires practically-applied demonstration of intellect and an ability to interface effectively with R&D, supply chain and commercial counterparts with credibility
• 5 to 6 plus years’ experience in Regulatory Affairs

Care to join us. Find out what life at Haleon is really like www.haleon.com / careers /

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