Senior CMC Regulatory Manager A fantastic opportunity for a CMC Regulatory Manager has opened within a rapidly growing Cell and Gene Therapy company based in the Hertfordshire area... View Job
Regulatory Compliance Chemist Hyper Recruitment Solutions are currently looking for a Regulatory Compliance Chemist to join a leading Pharmaceutical company based in the Essex area... View Job
Regulatory Affairs Manager A leading Cell and Gene Therapy Company are looking for a Regulatory Affairs Manager to join their team based in Central London. As the Regulatory Aff... View Job
We are currently looking for a Regulatory Affairs Manager to join a leading Pharmaceutical Company based in Hertfordshire. This is an exciting opportunity for a Regulatory Affairs Professional who is looking to take ownership of their own activities as well as expand their skills set into Project Management of client API Manufacturing projects.
As the Regulatory & Project Manager you will spend the majority of your time maintaining current registrations as well as ensuring the new registration of Active Pharmaceutical Ingredients but will also speak with and manage client projects.
KEY DUTIES AND RESPONSIBILITIES:
Your duties as the Regulatory Affairs Manager will be varied however the key duties and responsibilities are as follows:
1. Manage the Life cycle for existing API products including the review, editing and submission the required documentation.
2. Work cross functionally to support the generation of information for new ASMF (Active Substance Master Files).
3. Ensure that all staff are trained to support ASMP and CEP submissions.
4. Manage new API client projects and ensure that specific project timelines are met.
To be successful in your application to this exciting opportunity as the Regulatory Affairs Manager we are looking to identify the following on your profile and past history:
1. Relevant degree in a Life Sciences discipline (e.g. Chemistry, Pharmacology, Pharmacy etc.) in addition to some experience of working in a Regulatory Affairs environment.
2. Proven industry experience in the Manufacturing of API's and will as experience of the Regulatory activities in relation to the registration of ASMF within EU, US and RoW regions.
3. A working knowledge and practical experience working with the EDQM to obtain a CEP will be beneficial in your application.
Hyper Recruitment Solutions Ltd (HRS) is an Equal Opportunities employer who are certified by Investors in People for talent development. We therefore welcome applications for any interested parties 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 professionals and scientists. We look forward to helping you with your next career moves.