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Senior Regulatory Affairs Specialist, Reading
Client:
Cpl Life Sciences
Location:
Reading, United Kingdom
Job Category:
Other
EU work permit required:
Yes
Job Views:
4
Posted:
13.04.2025
Expiry Date:
28.05.2025
Job Description:
I am looking to speak with Senior Regulatory Affairs professionals looking for a long-term contract with a Pharmaceutical Manufacturing organisation based in Reading.
The UK and Ireland Regulatory Affairs Department is responsible for leading the regulatory strategy for a large portfolio of medicinal products and vaccines.
In this role, our team engages with Health Authorities (MHRA, HPRA, EMA) to ensure the compliant pre-licensing application and post-licensing life-cycle management activities for the Marketing Authorisations held for these products for the UK and Ireland.
The portfolio covers a wide range of disease areas including neurological diseases, diabetes, respiratory, cardiovascular, oncology and rare diseases.
Job Purpose:
- To obtain, manage and maintain product Marketing Authorisations in line with business goals and legal requirements.
- To conduct associated regulatory activities for the specified markets with minimal supervision, and to contribute to the implementation and leading of projects.
- To mentor/coach junior members of staff, supporting regulatory, product and or therapeutic area knowledge.
Main Responsibilities:
- Co-ordinates, prepares, submits and follows up registration applications to the UK and/or Irish regulatory authorities, expeditiously and to high standards, to ensure that marketing authorisations are obtained and maintained in line with the company’s plans and goals.
- Supports the launch of new products and life cycle management of the existing portfolio.
- Assist and provide support in the preparation, distribution and follow up of registration documentation required in the EU (particularly UK and Ireland).
Hybrid – 3 office days a week (office days would need to align with team days, with one being a Monday or a Friday).
If interested please apply with your updated CV and we can discuss in more detail.
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