Regulatory Affairs Product Lifecycle Management Associate

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.

The Product Lifecycle Management (PLM) team coordinates and delivers the timely preparation of global renewal applications and safety reporting activities, including Periodic Benefit-Risk Evaluation Reports (PBRERs), for the company portfolio. The team works efficiently once the required data and documents are available from relevant sources, including R&D, manufacturing sites and reference markets.

PLM also supports Risk Management Plan (RMP) strategy and submissions, and owns the Price Certificate and PWCR processes.

In addition, the team supports Category and Operating Unit innovation and geographic expansion projects across all brands, as well as overseeing divestments and acquisitions.

The PLM team is the Centre of Excellence for Export Certification, including Certificates of Pharmaceutical Product (CoPPs) and Certificates of Free Sale (CFSs), legal documentation for all legal entities, including Powers of Attorney and Letters of Authorisation, and market-specific requirements, including legalisation expertise.

This role is responsible for several products with different legal statuses, and will cover medicines, cosmetics and medical devices. The position requires an understanding of the regulatory differences and associated requirements for these product types.

Role and Responsibilities

Planning

• Maintain a comprehensive understanding of global regulatory requirements, particularly for lifecycle maintenance activities such as renewal applications and safety reporting activities, to enable effective planning and communication with stakeholders, including Safety and CMC, and support timely, complete document delivery.
• Agree and communicate regulatory submission plans with relevant markets to meet renewal and safety reporting timelines, expectations and milestones.
• Proactively monitor regulatory intelligence for changes to market requirements and communicate relevant updates to stakeholders.
• Partner with Global Regulatory colleagues, including CMC, Medical, Manufacturing and Operating Units, to ensure clear communication and shared understanding of priorities, planned activities, such as renewals, and process requirements.
• Contribute as the regulatory representative on priority project initiatives, ensuring appropriate regulatory support is provided to deliver project objectives.
• Demonstrate broad, forward-looking thinking and make regulatory decisions informed by consumer needs and market insights.

Implementation

• Manage the execution and delivery of right-first-time dossiers, ensuring filings for planned initiatives are completed in line with agreed timelines.
• Prepare, or ensure the availability of, high-quality documents required to support renewal and safety reporting applications, and support maintenance and lifecycle management in accordance with market data requirements.
• Provide Centre of Excellence support to Operating Units and Local Operating Companies for regional and local initiatives, such as new product introductions and geographic expansion, where legalised documentation is required and activities are aligned with CMC priorities.Resolve unexpected issues and challenges, minimising impact through timely communication and escalation to peers and senior management where required.

Knowledge

• Demonstrate expertise in required regulatory IT systems, including Veeva Vault.Critically assess processes and systems, initiating improvements where required.

General

• Act as the regulatory expert within project teams, working with cross-functional, Category and Regional colleagues to provide regulatory strategy and solutions to overcome issues and challenges.
• Take ownership of regulatory-specific processes and establish improved ways of working and communication across Global Regulatory, Operating Units and manufacturing sites. 
  

Essential Experience

• This is a role that requires a basic understanding of what Regulatory Affairs is and how this fits within the lifecycle of a product.
• 1-3+ years of relevant experience
• BSc or relevant job-related experience
• Strong scientific background - Pharmaceutical or Life Sciences

 Job Posting End Date

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.