Regulatory Affairs Associate

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 categoryleading 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.

Join our dynamic team at Haleon as a Regulatory Affairs Associate, where you will manage the preparation and submission of regulatory documents to ensure our products comply with local regulations and reach the market efficiently. You will collaborate with key stakeholders, manage the submission of the regulatory related activities to ensure timely approval and implementation, and support the development of promotional materials, all while contributing to a high-performing team.

This role will provide YOU the opportunity to lead key activities to progress YOUR career.  These responsibilities include some of the following:

Key Responsibilities & Accountability

• Manage preparation of new regulatory documents, dossiers, and applications to enable new products to be launched and maintained in market, with the correct alignment and compliance to regulations, proactively seeking innovative and rapid path to market.
• Obtain all relevant authorizations, necessary to place Haleon products in Hungary, ensures that these are received as early as possible.
• Submit all required new product files developed for Hungary.
• Perform all specific tasks (update registration information of products by submitting notifications, variations, and renewals etc) required in order to gain and maintain product licenses up-to-date, valid and in compliance with the legal requirements in Hungary.
• Ensure the deadlines for product launch, new product application and variations submissions are kept.
• Approve the products labelling/artwork in line Haleon and local legislation requirements.
• Manage labelling text and packaging components to ensure compliance with local registered details and corporate prescribing information.
• Analyze regulatory issues and communicate with key stakeholders. Work together to help develop plans to mitigate, so we can deliver science that is robust and aligned with business needs.
• Actively contributes to the activity of a high performing local team, including looking for ways to improve performance.
• Build relationships with key stakeholders and represent Haleon in an appropriate manner according to company values, to present Haleon policies and strategies.
• Manage compliance within defined portfolio/activity streams in line with Haleon expectations - support key processes and ways of working (eg, in relation to Haleon CMC, quality, product labelling requirements as well as local regulations)

• Work together with other functions (eg, marketing, quality and supply chain) to deliver innovations and value engineering projects.

• Support the development of the strongest claims/advertising and promotion possible within the regulations, ensuring risks are appropriately addressed and communicated.

• Check and approve promotional and advertising materials, ensuring that materials comply with Haleon and local requirements.

• Obtain necessary approvals from competent authorities for the promotional and advertising materials before dissemination in a timely manner. Respond to the authority’s comments, offer supporting evidence and argumentation for our claims, to obtain timely approval.

• Proactively managing the impact of regulatory changes within defined scope of responsibility on the business

• Maintain required regulatory compliance databases, systems, and processes.

• Maintain high levels of knowledge on the science of products within defined portfolio.

Requirements

Education: Minimum level of education: BA or B.Sc in Life science/Pharmaceutically related science (Chemistry, Pharmacy, Biochemistry, Biology, Medical Engineering)

Preferred level of education: B.Sc., M.Sc. or equivalent in Regulatory Affairs, Pharmacy

Language: Hungarian, English (fluent