Job Description

Hello. Were Haleon. A new world-leading consumer health company. Shaped by all who join us. Together, were 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. Whats more, were achieving it in a company that were in control of. In an environment that were co-creating. And a culture thats uniquely ours. Care to join us. It isnt 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, were 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. Its an opportunity to be part of something special.
Job Purpose:
The purpose of this role is to execute 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. Preparation of CMC sections of new registration files, TMACs, briefing books, clinical trials applications/INDs, CMC variations, responses to Regulatory Agency technical questions and other documents as needed, with support from supervisor.
Interacts with colleagues in other global functions (e.g. Category, BU, Quality and Supply Chain) 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.
Preferred Skills & Qualification:
Degree in a pharmaceutical or life science or equivalent regulatory experience.
3-5 years experience in Regulatory Affairs. Knowledge in Quality, product development, manufacturing, experience in systems, regulatory information management, compliance and ideally OTC experience.
Responsible for CMC regulatory matters relating to registrations and/or maintenance of business activities (including variations and renewals) for assigned product portfolio (e.g. OTC & Wellness) globally (e.g. Wider Asia, EMEA LATAM)
Preparation of CMC sections of new registration files, CMC variations, responses to Regulatory Agency technical questions and other documents as needed, with support from supervisor
Interacts with colleagues in other global functions (e.g. Category, BU, Quality and Supply Chain) to deliver high quality CMC dossiers, 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.
Care to join us. Find out what life at Haleon is really like www.haleon.com/careers/
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.
As you apply, we will ask you to share some personal information, which is entirely voluntary. We want to have an opportunity to consider a diverse pool of qualified candidates and this information will assist us in meeting that objective and in understanding how well we are doing against our inclusion and diversity ambitions. We would really appreciate it if you could take a few moments to complete it. Rest assured, Hiring Managers do not have access to this information and we will treat your information confidentially.
Haleon is an Equal Opportunity Employer. All qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class.
Accommodation Requests
If you require a reasonable 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 accommodations you are requesting. Well provide all reasonable accommodations to support you throughout the recruitment process and treat all information you provide us in confidence.