Regulatory affairs lead Work, Jobs in Maidenhead (with Salaries)

PV Systems and Processes Lead x2
CSL Seqirus —Maidenhead
- Full-time
- Continuous improvement
- No degree
- Leadership
Principal Regulatory Affairs Specialist (UK, IVDR) Remote UK
Cepheid —Amersham
- Full-time
- Remote
- Master's degree
- Databases
- Bachelor's degree
- Annual leave
Patient-Centered Outcomes Research (PCOR) Lead (UK)
UCB —Slough
- Doctoral degree
- Master's degree
- Leadership
Associate Director Global CMC QU – Clinical GMP/GDP
Kyowa Kirin International plc —Marlow
- £80,000 - £140,000 a year
- Full-time
- Bachelor's degree
- No degree
- Leadership
Head of Global Labelling
CSL Seqirus —Maidenhead
- Full-time
- Management
- Continuous improvement
- Leadership
Quality Assurance & Regulatory Affairs Executive - Maternity Cover
TensCare Ltd —Epsom
- £35,000 - £42,500 a year
- Temporary
- Hybrid work
- Bachelor's degree
- Continuous improvement
- Team management
- Profit sharing
- Work from home
Quick apply
Strategy & New Product Planning Associate
Biogen —Maidenhead
- Full-time
- Hybrid work
- Microsoft Powerpoint
- Master's degree
- Analysis skills
3d
Director of Public Affairs, UK
Abbott Laboratories —Maidenhead
- Full-time
- Bachelor's degree
- Budgeting
- Communication skills
Associate Director Global CMC QU – Clinical GMP/GDP
Kyowa Kirin International —Marlow
- £66,814 - £134,641 a year
- Full-time
- Bachelor's degree
- No degree
- Leadership
Quick apply
Local Study Associate Director
IQVIA —Reading
- Full-time
- Remote
- English
- Bachelor's degree
- No degree
- Work from home
Sr Director, Drug Development Lead
IQVIA —Reading
- Full-time
- Remote
- Management
- Doctoral degree
- Master's degree
- Work from home
6d
Director - Regulatory Platforms
CSL Behring —Maidenhead
- Full-time
- Computer Science
- Bachelor's degree
- Travel
Regulatory Compliance Supervisor (m/f/x)
3M —Bracknell
- Full-time
- Engineering
- Research
- Master's degree
- Flexible schedule
Senior Benefits Risk Management Lead
Bayer —Reading
- £110,000 - £130,000 a year
- Full-time
- Hybrid work
- English
- Databases
- Continuous improvement
- Annual leave
- Employee discount
Global Medical Affairs Associate Director - Metabolic & Dermato-Oncology
Recordati —Hemel Hempstead
- Full-time
- Hybrid work
- English
- Quality control
- Travel
Northern Europe Regulatory Affairs Director
Kenvue —Reading
- Hybrid work
- Management
- English
- Analysis skills
Global Manager, Performance Validation - Personal Care
Elementis —Ascot
- Full-time
- Hybrid work
- English
- Bachelor's degree
- Quality control
13d
Vice President, Medical Affairs Rare Diseases
Recordati —Hemel Hempstead
- £245,552 - £368,358 a year
- Full-time
- Hybrid work
- Management
- Doctoral degree
- English
- Annual leave
Director, Medical Affairs EMEA
Kenvue —Reading
- Hybrid work
- Management
- Continuous improvement
- Travel
- Annual leave
Regulatory Affairs Manager
pladis —Chiswick Park Station
- Full-time

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regulatory affairs lead jobs near maidenhead

PV Systems and Processes Lead x2

CSL Seqirus -
Maidenhead

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Job details

Full-time

Qualifications

Quality control corrective actions
Non-conformance investigation
Defect resolution root cause analysis
Corrective and preventive actions (CAPA)
Compliance audits
Quality assurance
Continuous improvement
Continuous improvement cycles oversight
Clinical compliance monitoring
Good Clinical Practice (GCP)
Pharmaceutical industry setting experience
Root cause analysis
Leadership
Communication skills
Internal quality assurance
Good Clinical Practice (ICH-GCP) guidelines
Corporate regulatory compliance oversight

Full job description

Entity: CSL Seqirus

Job Category: Quality

Job Family: Quality Assurance

Job Type: Full Time

Location: Maidenhead, Berkshire, United Kingdom

Employer Reference: R-274200

Job Description

PV Systems & Process Lead

Patient safety depends on pharmacovigilance systems that work — and work well. In this role, you'll be at the centre of keeping CSL's global PV system compliant, continuously improving, and inspection-ready across Global Clinical Safety & Pharmacovigilance, Global Regulatory Affairs, Global Medical Affairs, affiliates, and commercial operations.

This is a role for someone who thrives at the intersection of regulatory expertise and practical problem-solving — someone who can spot a systemic compliance risk, build the relationships to address it, and drive the change that makes it stick.

What you'll do

You'll own the quality and compliance infrastructure that underpins CSL's PV system. Day-to-day, that means:

Providing expert GVP and PV legislation guidance across the organisation, and ensuring that regulatory changes translate into timely, concrete action
Leading investigation and resolution of deviations and non-compliances, including root cause analysis, CAPA development, and effectiveness tracking
Reviewing procedural documents across GCSP, GRA, and GMA for GVP compliance
Serving as the primary inspection coordinator for health authority and third-party PV audits in your region — from readiness planning through to CAPA close-out
Tracking quality and performance indicators, identifying trends, and escalating risks appropriately
Delivering PV quality training and sharing best practices across functions and affiliates

You'll also contribute to the broader audit programme and help shape the long-term PV audit strategy, in line with GVP Module IV.

What you'll bring

A science or life sciences degree (or equivalent through experience), plus significant experience in the pharmaceutical industry — mainly in PV or GxP Quality Assurance
Hands-on experience managing regulatory inspections and PV audits
Strong command of GVP regulations, ICH GCP, and relevant international requirements
Proven ability to lead deviation and CAPA management processes
The communication and leadership skills to influence across functions, regions, and seniority levels

About CSL Seqirus

CSL Seqirus is part of CSL. As one of the largest influenza vaccine providers in the world, CSL Seqirus is a major contributor to the prevention of influenza globally and a transcontinental partner in pandemic preparedness. With state-of-the-art production facilities in the U.S., the U.K. and Australia, CSL Seqirus utilizes egg, cell and adjuvant technologies to offer a broad portfolio of differentiated influenza vaccines in more than 20 countries around the world.

To learn more about CSL, CSL Behring, CSL Seqirus and CSL Vifor visit https://www.csl.com/ and CSL Plasma at https://www.cslplasma.com/.

Our Benefits

For more information on CSL benefits visit How CSL Supports Your Well-being | CSL.

You Belong at CSL

At CSL, Inclusion and Belonging is at the core of our mission and who we are. It fuels our innovation day in and day out. By celebrating our differences and creating a culture of curiosity and empathy, we are able to better understand and connect with our patients and donors, foster strong relationships with our stakeholders, and sustain a diverse workforce that will move our company and industry into the future.

To learn more about inclusion and belonging visit https://www.csl.com/careers/inclusion-and-belonging

Equal Opportunity Employer

CSL is an Equal Opportunity Employer. If you are an individual with a disability and need a reasonable accommodation for any part of the application process, please visit https://www.csl.com/accessibility-statement.

Apply Now

Refine Your Search

regulatory affairs lead jobs in maidenhead

PV Systems and Processes Lead x2

Principal Regulatory Affairs Specialist (UK, IVDR) Remote UK

Patient-Centered Outcomes Research (PCOR) Lead (UK)

Associate Director Global CMC QU – Clinical GMP/GDP

Head of Global Labelling

Quality Assurance & Regulatory Affairs Executive - Maternity Cover

Strategy & New Product Planning Associate

Director of Public Affairs, UK

Associate Director Global CMC QU – Clinical GMP/GDP

Local Study Associate Director

Sr Director, Drug Development Lead

Director - Regulatory Platforms

Regulatory Compliance Supervisor (m/f/x)

Senior Benefits Risk Management Lead

Global Medical Affairs Associate Director - Metabolic & Dermato-Oncology

Northern Europe Regulatory Affairs Director

Global Manager, Performance Validation - Personal Care

Vice President, Medical Affairs Rare Diseases

Director, Medical Affairs EMEA

Regulatory Affairs Manager

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Job Description

About CSL Seqirus

Our Benefits

You Belong at CSL

Equal Opportunity Employer

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