Regulatory Coordinator

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.

About the Role

The purpose of this role is to support CMC product responsible in executing CMC regulatory activities for new products registrations and life-cycle maintenance (including variations and renewals) for a defined portfolio of products.

Key Responsibilities:

• Responsible for CMC regulatory matters relating to registrations and/or maintenance of business activities (including variations and renewals) for assigned product portfolio, such as mentioned below,
• Accomplish and assist CMC product responsible in carrying out “administrative” tasks 
• Work towards improving quality of the information available in our databases
• Internal Compliance checks: Review of the PROTRAC (internal tracker which monitors CMC has completed all the steps from WI/ SOP till dispatch date) on fortnightly basis.
• Update standard requirement table & assist in archiving the CMC/ Regulatory surveys
• Baseline/ Eurasia dossier by creating the CMACs / TMACs/ Normative documents/ etc.
• Follow-up with key/ major LOC/BUs in discussion (as necessary):  For Veeva update on submission / approval dates. For ex. For GREEN project, CMC is responsible for following with LOC/BUs as necessary.
• Interacts with colleagues in other global functions (e.g. FSS and Supply Chain) and Regulatory Affairs sub-functions (Category and Regional) to deliver high quality CMC dossiers, TMACs, documents & materials to local Regulatory Affairs in accordance with business priorities. Ensures close partnership with authors, assuring technical congruency and regulatory compliance.
• Applies processes and procedures to maintain up-to-date technical product records/information and support adequate controls.
• 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.

Why you?

Basic Qualifications:

• Degree in a pharmaceutical or life science or equivalent regulatory experience - Science, Life Sciences - Medicinal/Medical Device/Cosmetic Regulation
• 3+ years’ Regulatory Affairs experience in systems, regulatory information management, compliance and ideally OTC experience
• Ensures basic level of scientific/regulatory understanding

 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.