Senior Regulatory Affairs Specialist - Hybrid (Warrington

Warrington
6 days ago
Create job alert

Senior Regulatory Affairs Specialist
Location: Warrington (Remote/Hybrid)
Rate: £80 per hour
Working Hours: Monday -Friday, flexible between 09:00-18:00

We are seeking a Senior Regulatory Affairs Specialist to join the Life Sciences Group (LSG) EMEA Regulatory Affairs team. In this role, you will lead and support EU Member State notification activities for IVDR CDx performance studies using leftover samples.

You will play a key role in ensuring regulatory compliance while supporting business growth and maintaining competitive advantage across the CDx portfolio.

Key Responsibilities

Lead EU Member State notification activities for IVDR CDx performance studies
Prepare, review, and submit regulatory documentation to Competent Authorities and Ethics Committees
Act as the primary contact for regulatory authorities and respond to queries
Collaborate cross-functionally (Clinical, Medical, Legal, Quality, Project Management)
Maintain accurate regulatory documentation and records
Provide regulatory guidance on study design and submission strategyMinimum Qualifications

Bachelor's degree in Life Sciences, Biomedical Sciences, or related field
3+ years of Regulatory Affairs or Clinical Regulatory experience (IVD, medical device, or pharma)
Experience with EU submissions and Competent Authorities/Ethics Committees
Working knowledge of IVDR (EU 2017/746), especially performance studies
Strong project management and multitasking skills
Excellent written and verbal English communicationSkills & Attributes

Proactive, solution-oriented, and able to work under pressure
Comfortable working independently in a matrix environment
Strong cross-functional collaboration skills
Willingness to travel (10-15%)
Proficient in standard PC/software toolsWork Environment & Benefits

Remote or hybrid working model
International, cross-functional team environment
Laptop and accessories provided
Opportunity to contribute to high-impact regulatory project

Related Jobs

View all jobs

Senior Regulatory Affairs Specialist

Regulatory Affairs Specialist

Senior Regulatory Affairs & QA Specialist - Medical Devices

Head, PV and Regulatory QA

Associate Director, External Manufacturing Lead (Home Based / Remote)

Senior Project Manager, R&D: Drug Development

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.

CSL Behring Jobs UK: Careers, Salaries, Locations & How to Get Hired

CSL Behring is one of the world’s leading biopharmaceutical companies specialising in plasma-derived therapies, recombinant proteins, gene therapy, vaccines, and rare disease treatments. If you’re a UK job seeker looking for a career with real purpose, strong scientific standards, and long-term progression, CSL Behring roles can be an excellent fit, especially if you have experience in biotech, pharma manufacturing, quality, engineering, supply chain, clinical operations, regulatory, pharmacovigilance, or commercial. This guide is written for UK candidates who want to understand what CSL Behring jobs typically involve, which roles to target, where opportunities may be based, what skills recruiters look for, and how to tailor your application to stand out.

How Many Biotechnology Tools Do You Need to Know to Get a Biotech Job?

If you are trying to break into biotechnology or progress your career, it can feel like the list of tools you are expected to know is endless. One job advert asks for PCR, another mentions cell culture, another lists bioinformatics pipelines, automation platforms or GMP systems. LinkedIn makes it worse, with people sharing long skills lists that make you wonder if you are already behind. Here is the reality most biotech employers will not say out loud: they are not hiring you because you know every tool. They are hiring you because you understand biological systems, can work accurately and safely, follow protocols, interpret results and contribute reliably to a team. Tools matter, but only when they support those outcomes. So how many biotechnology tools do you actually need to know to get a job? The answer depends on the role you are targeting, but for most job seekers it is far fewer than you think. This article breaks down what employers really expect, which tools are essential, which are role-specific, and how to focus your learning so you look employable rather than overwhelmed.

What Hiring Managers Look for First in Biotechnology Job Applications (UK Guide)

Hiring managers in biotechnology do not start by reading your CV word for word. They scan for credibility, relevance and risk. In a regulated, evidence-driven sector like biotech, the first question is simple: is this person safe, competent and genuinely capable of contributing in this environment? Whether you are applying for roles in research, manufacturing, quality, regulatory, clinical, bioinformatics or commercial biotech, the strongest applications make the right signals obvious in the first 10–20 seconds. This in-depth guide explains exactly what hiring managers in UK biotechnology look for first, how they assess CVs, cover letters and portfolios, and why capable candidates are often rejected. Use it as a practical checklist before you apply.