Regulatory Affairs Manager

Job Type:
Job Sector:
South East
United Kingdom
£50 to £60 per hour
Salary Description:
£50 - £60 per hour
Quanta Consultancy Services Ltd
Job Ref:

A highly respected Biopharmaceutical client with a flowing pipeline is now looking to recruit a Regulatory Affairs Manager on a contractual basis for a period of 12 months.

Working alongside a team of other Regulatory professionals, this role will support one or more products from a regional (extended Europe) regulatory perspective. 
The incumbent will ensure that our client acquires and maintains all the required licenses in order to support clinical trials and further development of investigational medicinal products. 


- Plans and manages regulatory submissions for products within our client’s portfolio in compliance with global filing plans and local regulatory requirements. 
- Under general supervision, implements product related regulatory strategies, Regulatory Affairs processes and activity planning in accordance with national legislation and regulatory requirements. 
- Provides content guidance for regional regulatory documents and guidance on regional regulatory mechanisms to optimize product development (e.g. expediting FIH studies, Orphan Drug, Fast Track, compassionate use and paediatric plans) 
- Ensures regional needs are well defined and implemented in collaboration with relevant regional cross-functional stakeholders and support regional label negotiation activities 
- Develop predictions for expectations and risks associated with outcomes by regulatory agencies 
- Maintain an awareness of new and developing legislation, regulatory policy and technical Regulatory guidance relating to our clients products. 
- Performs regulatory research to obtain relevant histories, precedence and other information relevant to regional product development. 
- Under supervision evaluates and communicate impact of relevant regional regulations, guidance’s, current regulatory environment and competitor labelling.

Basic qualifications: 

- Scientific Degree and demonstrated experience in a similar role 
- Team work 
- Communication skills - both oral and written - Ability to understand and communicate scientific/clinical information 
- Knowledge of drug development and experience in regional regulatory environment 
- Regulatory principles, such as: Working with policies, procedures and SOP’s, Knowledge of legislation and regulations relating to medicinal products and awareness of the registration procedures in region for development, MA, post approval changes, extensions and renewals. 
- Ability to anticipate and prevent potential issues, resolve conflicts and develop a course of action leading to a beneficial outcome.

If you think this role could be for you, please apply today!

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Contact Details:
Quanta Consultancy Services Ltd
Tel: (0) 1442 860 542
Contact: Kathryn Taylor

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