Lead Regulatory Affairs Specialist - Drug Development

£70000 to £90000 per annum
23 Oct 2018
20 Nov 2018
Georgia Walden
Contract Type
Full Time
We are currently looking for a Lead Regulatory Affairs Specialist - Drug Development to join a leading Pharmaceutical contract testing company based in the Cambridgeshire area. As the Lead Regulatory Affairs Specialist - Drug Development you will be responsible for providing expert Regulatory advice for the drug discovery process as well as offering a range of regulatory services for internal and external customers.


Your duties as the Lead Regulatory Affairs Specialist - Drug Development will be varied however the key duties and responsibilities are as follows:

1. You will offer expert Regulatory advice to internal and external customers including regulatory strategy, project management and preparation, review and submission of regulatory 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 Lead Regulatory Affairs Specialist - Drug Development 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 product development environment.

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 Module 4 and Module 5 will be beneficial to your application and experience with Drug Development Regulations is vital

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

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.