Haleon Life Sciences Job – Global Regulatory Affairs Role
Name of the Post: Manager- Global Regulatory Affairs CMC
Req. ID – 513662-gsknch
Job Description –
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.
The purpose of this role is to be responsible for the regulatory CMC activities for new registrations and life-cycle maintenance (including variations and renewals) for a defined portfolio of products within the category and in particular the regulatory CMC strategy of new
product developments and major CMC changes
- 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, PIFs, MDTFs, briefing books, clinical trials applications/INDs, CMC variations, responses to Regulatory Agency technical questions.
- Interacts with colleagues in other global functions (e.g. Category, BU, Quality and Supply Chain) to deliver high quality CMC sections for dossiers, PIFS or MDTFs including 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.
- 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.
We are looking for professionals with these required skills to achieve our goals:
- Bachelor’s degree/master’s degree in Life science/Pharmaceutically-related science (Chemistry, Pharmacy, Biochemistry, Biology, Medical Engineering) other related discipline.
- Experience with standard operating procedures, and legislative requirements
Regulatory document management experience, including experience with Documentum databases and MS team sites
- 12+ years’ experience in regulatory operations (or similar) role