job details for:
Regulatory affairs - Regulatory Affairs Consultant Jobs - Hertfordshire

Regulatory affairs - Regulatory Affairs Consultant Jobs - Hertfordshire (Job Ref: WR/JOBS/25432-11836)

Job Description :

Flame Pharma - Regulatory Affairs – Regulatory Affairs Consultant Job– Hemel Hempstead, Hertfordshire

Salary: Up to £50k

Flame Pharma is working alongside a leading Pharma company that provides drug development and regulatory services on a global basis to the pharmaceutical and biotechnology sectors through its operating companies in Europe, the USA and Japan. This is a forward thinking niche organisation.

The Role:

Reporting to the Director of Regulatory Strategy you will work on individual projects or as part of a project team. You will interface with clients to provide specific regulatory consultancy as well as having an operational role in the preparation of documents, reports and regulatory submissions. Project based activities will be variable depending on the nature of the projects contracted to Client Regulatory. These will fall mainly within the areas of regulatory affairs concerned with biological and biotechnology products, pharmaceuticals and medical devices but could also involve other areas such as veterinary products, drug delivery systems, neutraceuticals, cosmetics and borderline substances. Project work may be performed alone or as part of a team depending on the size and nature of the project.

The Person:

The ideal candidate will be a Regulatory Consultant with direct regulatory affairs experience, preferably gained in a pharmaceutical or biotechnology company, a regulatory affairs consultancy or a regulatory agency. They will ideally have early and late stage drug development, clinical trial and marketing authorisation dossier preparation and procedure management, familiarity with CMC, preclinical and clinical aspects, scientific advice, orphan drugs, paediatric investigation plans. The candidate will also have the relevant experience with biotechnology products which is especially valuable & preclinical and clinical regulatory development is also desirable. 

Key Words:

Regulatory Affairs, Senior Regulatory Affairs Consultant, Pharmacovigilance, Drug Safety, Director, Manager, Management, Clinical Research, Clinical Trials, Medical, Clinical, CRO, Study Management, Clinical Management, Pharmaceutical, Career, Research, Hertfordshire, Job, Recruitment