RA CMC Experienced Manager

Welcome to Haleon. Were a purpose-driven world-class consumer company putting everyday health in the hands of just three years since our launch weve 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 its 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.

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 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.

About the role

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 life-cycle maintenance of business activities (including variations and renewals) for assigned product portfolio. Preparation of CMC sections of new registration files CMC variations responses to Regulatory Agency technical questions.
• Interacts with colleagues in other global functions (e.g. Supply Chain) and Regulatory Affairs subfunctions (Category and Regional) to deliver high quality CMC sections for dossiers 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.
• Effectively communicates regulatory technical requirements and guidelines facilitating timely and complete submissions. Develops up-to-date knowledge with regard to technical guidelines and regulatory requirements as well as technical trends.

Qualifications and skills

Essential

BA or BSc Life science/Pharmaceutically-related science (Chemistry Pharmacy Biochemistry Biology Medical Engineering)

5 to 10 years experience in Regulatory Affairs.

Knowledge in Quality product development and manufacturing. Experience in writing registration dossier.

Business English level

Full Product lifecycle support experience is preferred.

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.

Were 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.

Job Posting End Date

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. Its 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.

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. Well provide all reasonable adjustments to support you throughout the recruitment process and treat all information you provide us in confidence.

The Haleon recruitment team will contact you using a Haleon email account (@). If you are not sure whether the email you received is from Haleon please get in touch.