Job Title: Regulatory Affairs Manager Location: Maidenhead Contract: 12 months / hybrid 3 days onsite Hours: 37.5 per week Rates: £80-90p/h

SRG are looking for a regulatory affairs manager to join a leading pharmaceutical company based in maidenhead. As part of this role, you will be providing UK regulatory strategy recommendations to Area/Global teams to shape the global product development for new and existing products in line with business objectives. As well as supporting global product development strategy(s); outlining options for UK Scientific Advice/PIP/IMPD, coordinating preparation of briefing packages and much more.

Duties and Responsibilities Define, lead & conduct UK MAA, new indications (National, IRP) and product lifecycle (if appropriate) filing strategy(s), identifying risks and proposing mitigation. Act as project lead to build and execute MHRA submission activities: clinical trials, paediatric investigation plans, lifecycle management of licensed and/or unlicensed products Works with the Europe region Regulatory team to advocate for the affiliate's strategy objectives and timelines Serves as Health Authority liaison and interfaces with UK H...