S E C Recruitment Limited
This position could be based in Surrey or Cambridge with working from home flexibility also offered after they return to the office.
Working in this Consultancy you will have the opportunity to work with a broad spectrum of innovative life sciences companies: biotechnology, medtech and pharmaceutical organisations. Supporting clients throughout product development from design of global development plans and regulatory strategies to the implementation and submissions to regulatory agencies and payers. The Consultancy has a truly global feel and you will work with professional consultants across Europe (London, France; Switzerland and Denmark), as well as in the USA and India. The strength of this organisation are their people, rich in scientific knowledge and expertise in their fields their sense of collaboration and support is what ensures this companies reputation as a great place to work.
Job Profile As a Senior Regulatory Scientist you will be responsible for: *Contributing to the definition and implementation of regulatory strategies for development of innovative products, drugs and biologics *Writing, reviewing and assembling high quality regulatory submissions, such as, (but not limited to): Orphan Drug Designations (ODDs), Scientific Advice / Agency meeting briefing documents, Paediatric Investigational Plans (PIPs) and Paediatric Study Plans (PSPs), *Submissions of clinical trial applications (CTAs / INDs) for ATMPs, Marketing Authorisation Applications (MAAs) in Europe or New Drug Applications (NDAs)/Biologic License Applications (BLAs) in the US, *Variations and Extensions applications ; *Participate in due diligences; *Interacting with clients when required to discuss project progress, ensure and check Client satisfaction;
Knowledge and Experience We are looking for a candidate who has a minimum of 5 years previous experience working in a regulatory sciences and drug development, having had experience of working within a consultancy environment would certainly be an advantageous, if you do not have this experience a strong desire and knowledge of the different environment will be required. Project management and experience of interacting with regulatory authorities is required…… click apply for full job details