National AI Awards 2025Discover AI's trailblazers! Join us to celebrate innovation and nominate industry leaders.

Nominate & Attend

Regulatory Affairs Manager

Maidenhead
3 weeks ago
Create job alert

Job Title: Regulatory Affairs Manager

Location: Maidenhead

Contract: 12 months / hybrid 3 days onsite

Hours: 37.5 per week

Rates: £80-90p/h

Job Description

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 Health Authority for meetings to obtain optimal outcomes for patients and the company's portfolio
Ensures compliance within the regulatory department and collaborates with internal stakeholders, as appropriate, to ensure compliance with the company's policies and procedures to meet statutory, quality and business requirements within the overall strategy and objectives of the company
Quality control check members of staff's dossier prior to MHRA submission
Conduct impact assessment per regulatory updates
Responsible for ensuring effective planning, tracking, archiving of activities, especially submissions, internal memos and key correspondence. Ensures effective planning and tracking of activities via RIM systemMain Accountabilities

Develop & execute in association with UK Therapy Area Head (s) Europe region Regulatory team regulatory strategies for new MAA or indications
Ensures submission and content of MHRA new and product lifecycle applications are made in accordance with appropriate timings and requirements
Ensures appropriate and timely communication of regulatory and safety information as required by local regulation, company policies and procedures
Keeps up to date with all appropriate Regulatory issues and operate as a 'problem-solver', to provide effective resolution of regulatory issues occurring within the UK, with an appreciation of business needs and priorities and will escalate to the Director, Regulatory Affairs as necessary.
Builds business relationships with key internal stakeholders, including Europe region Regulatory Affairs, Medical Affairs, Market Access, Commercial and QA, as required to enable good cross-functional working.
Stays abreast of all Regulatory intelligence updates and is proactive regarding implementation of necessary legislation/regulation changes.

Experience and Qualifications

Life Sciences Degree or equivalent experience
Varied experience within UK or EU Regulatory Affairs, including development strategy, new MAA/Indications, clinical trials, paediatric investigation plans, license lifecycle management
Knowledge in specific therapeutic areas - Oncology
Excellent communication skills, both verbal and written
Effective influencing, tactical and presentation skills
Effective project management experience
Consultative and collaborative interpersonal style
Excellent English language skills
The ability to thrive in a changing environment and to re-prioritise workload to meet business needs.Carbon60, Lorien & SRG - The Impellam Group STEM Portfolio are acting as an Employment Business in relation to this vacancy

Related Jobs

View all jobs

Regulatory Affairs Manager

Regulatory Affairs Manager

Regulatory Affairs Manager

Regulatory Affairs Manager

Regulatory Affairs Manager

Regulatory Affairs Manager- Nutraceuticals

National AI Awards 2025

Subscribe to Future Tech Insights for the latest jobs & insights, direct to your inbox.

By subscribing, you agree to our privacy policy and terms of service.

Industry Insights

Discover insightful articles, industry insights, expert tips, and curated resources.

How to Present Medical Technology Solutions to Non-Technical Audiences: A Public Speaking Guide for Job Seekers

The medical technology (medtech) sector is advancing rapidly—introducing AI-powered diagnostics, wearable health monitors, robotic surgery, and remote patient care. But for these innovations to succeed, they must be understood, trusted, and adopted by a wide range of non-technical stakeholders. That’s why UK employers are now looking for medtech candidates who can do more than design great products—they want professionals who can clearly explain complex solutions to clinicians, patients, regulators, investors, and internal teams. This guide will help job seekers in the medical technology space master public speaking, with tips on presentation structure, slide design, storytelling techniques, and how to answer tough stakeholder questions with confidence and clarity.

Medical Technology Jobs UK 2025: 50 Companies Hiring Now

Bookmark this page—refreshed every quarter—so you always know who’s really scaling their med‑tech engineering, R&D & commercial teams. NHS backlog pressures, EU MDR deadlines, the UK’s Innovative Devices Access Pathway and record venture capital for digital health have triggered a hiring boom in 2025. Employers need design engineers, QA/RA specialists, clinical scientists, software and AI developers, product managers & field service engineers—right now. Below you’ll find 50 organisations that posted UK‑based medical‑technology vacancies or announced head‑count growth in the past eight weeks. They’re grouped into five quick‑scan categories so you can jump straight to the type of employer—and mission—that excites you. For every company we list: Main UK hub Example live or recent vacancy Why it’s worth a look (tech stack, impact, culture) Search any employer on MedicalTechnologyJobs.co.uk to view real‑time ads, or set up a free alert so fresh openings land straight in your inbox.

Return-to-Work Pathways: Relaunch Your Medical Technology Career with Returnships, Flexible & Hybrid Roles

Re-entering the workforce after a career break can feel daunting—especially in a highly regulated and innovation-driven field like medical technology. Whether you paused your career for parenting, caring responsibilities or another life chapter, the UK’s medical technology sector now offers a variety of return-to-work pathways. From structured returnships to flexible and hybrid roles, these programmes recognise the transferable skills and resilience you’ve developed, pairing you with mentorship, targeted upskilling and supportive networks to help you step back in with confidence. In this guide, you’ll discover how to: Understand the growing demand for medtech talent in the UK Leverage your organisational, communication and problem-solving skills in medtech contexts Overcome common re-entry challenges with practical solutions Refresh your technical and regulatory knowledge through targeted learning Access returnship and re-entry programmes tailored to medical technology Find roles that accommodate family commitments—whether flexible, hybrid or full-time Balance your career relaunch with caring responsibilities Master applications, interviews and networking specific to medtech Learn from inspiring returner success stories Get answers to common questions in our FAQ section Whether you aim to return as a medical device engineer, regulatory specialist, clinical applications expert or R&D project manager, this article will map out the steps and resources you need to reignite your medical technology career.