Principal Regulatory Affairs Manager - Non Clinical

£70000 to £90000 per annum
04 Jan 2019
01 Feb 2019
Georgia Walden
Contract Type
Full Time
Hyper Recruitment Solutions are currently looking for a Principal Regulatory Affairs Manager to join a leading consultancy based in the Cambridgeshire area. As the Principal Regulatory Affairs Manager you will be responsible for providing expert Regulatory advice for the drug discovery process in relation to Non-Clinical studies.


Your duties as the Principal Regulatory Affairs Manager will be varied however the key duties and responsibilities are as follows:

1. You will offer expert Regulatory advice including regulatory strategy, project management and preparation as well as review and submission of regulatory documentation. You will focus on Non-Clinical drug development programs and offer Regulatory advise to ensure the successful completion of Module 4 documentation.

2. You will act as the point of contact for key clients as well as supporting internal staff through scientific expertise.

3. You will contribute to the strategy and the direction of the team and work closely with sales and marketing to promote services offered.

4. You will maintain awareness of client, industry and regulatory developments and participate in training courses and conferences.


To be successful in your application to this exciting opportunity as the Principal Regulatory Affairs Manager we are looking to identify the following on your profile and past history:

1. Relevant degree in a Pharmaceutical Science e.g. Chemistry, Biology, Pharmacology, Toxicology etc. in addition to experience working in a Non-clinical environment where you have had a strong focus on Regulatory Documentation

2. Proven industry experience in a Regulatory Affairs environment with a strong understanding of the regulations and procedures for drug product licensing.

3. A working knowledge and practical experience with Modules 4 and 5 will be beneficial to your application and experience with Toxicology data is vital.

Key Words: Regulatory Affairs | Drug Development | Toxicology | Module 4 | Consultant | Client Facing | CRO | Expert | Pharmaceutical | Small Molecule | Large Molecule | Non Clinical | Toxicology

Hyper Recruitment Solutions Ltd (HRS) is an Equal Opportunities employer who are certified by Investors in People for our talent development. We welcome applications for any applicant who fulfil the role requirements for this position. HRS is a company exclusively supporting the science and technology sectors, and is made up of a collaboration of recruitment processionals and scientists. We look forward to helping you with your next career moves.