Regulatory 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 category-leading 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.

About the role

This is a Regulatory Associate role within the local market GB & Ireland Regulatory Affairs team.

To help ensure that existing UK & Ireland Product Licences are maintained, and new Marketing Authorizations are obtained, to allow continued and future sale of Consumer Healthcare products in the UK and Ireland.

To help ensure that all regulatory activity for a specified portfolio of products is planned and geared to commercial requirements.

To help ensure that all cosmetic products are sold in compliance with the relevant Cosmetic Product Regulations, that all medical devices are sold in compliance with the relevant Medical Device Regulations and that all pack and promotional copy complies with relevant legislation and Codes of Practice.

Key responsibilities:

To have responsibility with the support of a Regulatory Manager for a variety of marketed and development products and to be responsible for progressing the regulatory status of these products in the UK and Ireland.

To have a working knowledge of regulatory affairs and a general understanding of the regulatory environment across the UK and Ireland.

To prepare submissions which are both accurate and high quality and ensure all files and databases are effectively managed.

To maintain relationships with regulatory authorities to expedite smooth and timely assessment of applications.

To be responsible with the support of a Regulatory Manager for advising Commercial and Quality / Supply Chain functions on the regulatory implications of technical changes.

To develop knowledge of the regulations and guidelines and working practices of the EU and UK / IE Regulatory Authorities.

To have a working awareness of the relevant Medical Device Regulations and Cosmetic Product Regulations.

Identifies, challenges, develops and implements written procedures (e.g., local SOPs, work instructions), and proactively highlights opportunities for process improvement.

Responsible for highlighting own training needs and working with their manager to develop a training plan and achieve training goals.

Qualifications and skills

Essential

• Previous experience in UK regulatory affairs (and a minimum of 2 years’ experience working within the pharmaceutical industry) or with local market UK/IE knowledge of regulatory process and experience.
• Knowledge of the PAGB Code of Practice and UK and Ireland advertising regulations.
• Ability to work under limited supervision and prioritise workload accordingly.
• Demonstrated ability to show high attention to detail.
• Good customer focus and team player who has the ability to work with a large group of people. Within cross-functional teams, and shown flexibility to manage multiple projects in complex environments.
• Strong interpersonal and written communication skills with the ability to communicate effectively across business functions. Capable of delivering key communications with clarity, impact and passion
• Strong IT skills and ability to work with a variety of systems including Veeva, Microsoft applications and artwork systems.

Preferred

• High learning agility and has the ability and willingness to deal effectively with first-time situations or changing conditions.
• Self-reliant, flexible, with good time management skills, with ability to operate in an empowered environment with moderate guidance.
• Ability to identify and clarify problems for assigned tasks and implement appropriate solutions.
• For all products, collaboration with Commercial, Quality/Supply Chain, Manufacturing and R&D requires a good communicator with an ability to clearly prioritise work in accordance with business needs.
• Ability to partner, influence, network and negotiate with key internal / external stakeholders.

Please save a copy of the job description, as this may be helpful to refer to once the advert closes.

Diversity, Equity and Inclusion

At Haleon we embrace our diverse workforce by creating an inclusive environment that celebrates our unique perspectives, generates curiosity to create unmatched understanding of each other, and promotes fair and equitable outcomes for everyone.

We’re striving to create a climate where we celebrate our diversity in all forms by treating each other with respect, listening to different viewpoints, supporting our communities, and creating a workplace where your authentic self belongs and thrives.

We believe in an agile working culture for all our roles. If flexibility is important to you, we encourage you to explore with our hiring team what the opportunities are.