2 Regulatory Affairs jobs

We are looking for a Senior Medical Regulatory Writer for our global health communications client that has offices based in Manchester but with fully remote working available. Our client partners work with global pharmaceutical and biotechnology companies to provide expertise in strategic consultancy, multi-channel medical communications and regulatory documentation. Your role will be producing factual regulatory documentations in a wide range of therapy areas, making sure that all pieces of work are accurate and succinct. You will be able to use a wide range of regulatory documents, including protocols, clinical study reports, executive summaries, CTD clinical summaries, investigator brochures, clinical trial authorisations, narratives, regulatory response documents and clinical overviews. This really is a great opportunity to join an global agency that is able to grow your career further. In return you can expect, a competitive salary, ongoing training, pension, benefits, bonus...

Our client is part of an integrated agency that provides high-level technical competence and specialist expertise within medical communications, medical affairs, and market access. Due to continued growth, they are now looking for a Principal Regulatory Writer to join their established regulatory branch. This role can be fully remote, but you must be based in the UK and will have access to their offices in Cheshire and London if you prefer. Some locations within Europe may be considered. In this role, you will provide technical and scientific leadership of internal teams and be responsible for designated client accounts with budgets and deliverables up to £1–2 million. You will line manage, lead, and mentor a team working with a variety of clients throughout Europe and the US. Involved with the full range of regulatory offerings, some deliverables you will work on will include protocols, narratives, CSRs, briefing packages, regulatory responses, and CTD submission modules. It is...