Manager- Global Regulatory Affairs CMC
Role Overview
Regulatory Affairs CMC Manager
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.
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About the role
Regulatory Affairs CMC Manager
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.
Role 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, 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.
Basic Qualifications
- Specialisation in Life science/Pharmaceutically-related science (Chemistry, Pharmacy, Biochemistry, Biology, Medical Engineering)
- 5 to 6 plus years’ experience in Regulatory Affairs.
- Knowledge in Quality, product development and manufacturing
Preferred Qualifications
- B Pharm or B Sc’, ‘M Pharm, Masters (MBA , MS, MA), or PhD/PharmD/JD QP
- Location – this role is based in: Hyderabad
- 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.
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.
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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.
About Haleon
World-leading consumer health company improving everyday health.
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