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

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
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
SVP Regulatory Affairs & Quality Assurance
PrecisionLife Ltd —Oxford
- £85,000 - £105,000 a year
- Full-time
- Hybrid work
- Doctoral degree
- Computer Science
- Engineering
- Free parking
- Annual leave
Quick apply
Northern Europe Regulatory Affairs Director
Kenvue —Reading
- Hybrid work
- Management
- English
- Analysis skills
Regulatory Compliance Supervisor (m/f/x)
3M —Bracknell
- Full-time
- Engineering
- Research
- Master's degree
- Flexible schedule
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
Regulatory Affairs Manager
pladis —Chiswick Park Station
- Full-time
Head of Spectrum & Regulatory Affairs
Open Cosmos —Didcot
- Hybrid work
- Negotiation
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
Medical Affairs Coordinator
Servier —Slough
- Microsoft Office
- Databases
- Administrative experience
Director of Public Affairs, UK
Abbott Laboratories —Maidenhead
- Full-time
- Bachelor's degree
- Budgeting
- Communication skills
Sr Director, Drug Development Lead
IQVIA —Reading
- Full-time
- Remote
- Management
- Doctoral degree
- Master's degree
- Work from home
2d
Director - Regulatory Platforms
CSL Behring —Maidenhead
- Full-time
- Computer Science
- Bachelor's degree
- Travel
Director, Medical Affairs (Europe & International)
Immunocore —Oxford
- Management
- Doctoral degree
- Travel
Head, PV and Regulatory QA
CSL Seqirus —Maidenhead
- Full-time
- Bachelor's degree
- Continuous improvement
- Quality control
Vice President, Regulatory Affairs – ELMAC
Amgen —Uxbridge
- Doctoral degree
- Master's degree
- Bachelor's degree
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
RWE Strategy Lead, Developed Brands (UK)
UCB —Slough
- Hybrid work
- Doctoral degree
- Master's degree
- Travel

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regulatory affairs lead jobs near marlow

Associate Director Global CMC QU – Clinical GMP/GDP

Kyowa Kirin International plc -
Marlow

Apply Now

Job details

Permanent | Full-time
£80,000 - £140,000 a year

Qualifications

Quality management
Bachelor's degree
Clinical trials
Supply chain quality assurance
Pharmaceutical industry setting experience
Leadership
EU Good Distribution Practice (GDP)
Internal quality assurance

Full job description

Overview

Associate Director Global CMC QU – Clinical GMP/GDP

at Kyowa Kirin International plc

Marlow, UK or Hoofddorp, Netherlands

WE PUSH THE BOUNDARIES OF MEDICINE.

LEAPING FORWARD TO MAKE PEOPLE SMILE

At Kyowa Kirin International (KKI), our purpose is to make people smile. This means more than drug discovery and development; it is about embedding care into everything we do to make a difference every day for those that need it most. We’re an inclusive pharmaceutical company that takes time to understand what really matters to our patients, their families, and their healthcare professionals, helping our people to take bold actions that deliver life-changing solutions sooner. Our culture is rooted in our values: Teamwork, Commitment to Life, Innovation, and Integrity. They help us to push boundaries to deliver extraordinary impact and make KKI a brilliant place to work.

Job Purpose

You will be responsible for providing end-to-end quality oversight of clinical investigational medicinal products (IMPs) in accordance with EU GMP (EudraLex Volume 4), including Annex 13, and EU GDP Guidelines (2013/C 343/01)

The role provides independent QA oversight and regulatory support to EU Qualified Persons (QPs), ensuring that certification and release of investigational medicinal products is performed in compliance with EU legal and regulatory requirements. The position maintains quality oversight of CDMOs, packaging sites, laboratories, and Third-Party Logistics providers (3PLs) involved in the manufacture, storage, and distribution of clinical trial material (CTM)

Responsibilities

Key Responsibilities:

Provide QA oversight of clinical IMP manufacturing, packaging, testing, release, and distribution activities
Support EU Qualified Person (QP) certification and batch release processes
Ensure compliance with EU GMP Annex 13 requirements, including labeling, traceability, accountability, and retention samples
Review and approve GMP documentation, including batch records, CoAs, deviations, investigations, and quality events
Lead QA support for clinical technology transfers, process start-ups, and product lifecycle activities
Provide quality oversight of clinical supply chain operations, including transportation, temperature-controlled logistics, and distribution
Ensure clinical trial materials remain fully traceable throughout the supply chain.
Manage Quality Technical Agreements (QTAs) with CDMOs, laboratories, distribution partners, and 3PL providers
Plan, conduct, and support risk-based GMP and GDP audits of external partners.
Support regulatory submissions, inspections, and health authority interactions
Author, review, and maintain Clinical GMP/GDP procedures and quality system documentation
Ensure compliance with data integrity requirements, including EU GMP Annex 11 and ALCOA+ principles

Qualifications

Position Requirements:

Bachelor’s degree in a relevant scientific/technical discipline or equivalent experience in the pharmaceutical industry
Solid leadership experience within Pharmaceutical Quality in the pharmaceutical Industry, with significant exposure to EU Clinical GMP and GDP
Prior experience working with a Qualified Person (QP) responsible for investigational medicinal products, as well as experience in batch disposition (release), is preferred for success in this position
Strong knowledge of EU GMP (EudraLex Volume 4, Annex 13) and EU GDP Guidelines
Experience with biologics and/or small molecule clinical products.
Demonstrated ability to assess quality and regulatory risk and provide sound compliance judgments
Experience in QA, QC, auditing, or regulatory affairs within a clinical development environment

UK salary - £80,000-121,000

Netherlands salary - €93,000-140,000

Apply Now

Refine Your Search

regulatory affairs lead jobs in marlow

Associate Director Global CMC QU – Clinical GMP/GDP

PV Systems and Processes Lead x2

Principal Regulatory Affairs Specialist (UK, IVDR) Remote UK

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

SVP Regulatory Affairs & Quality Assurance

Northern Europe Regulatory Affairs Director

Regulatory Compliance Supervisor (m/f/x)

Associate Director Global CMC QU – Clinical GMP/GDP

Regulatory Affairs Manager

Head of Spectrum & Regulatory Affairs

Senior Benefits Risk Management Lead

Medical Affairs Coordinator

Director of Public Affairs, UK

Sr Director, Drug Development Lead

Director - Regulatory Platforms

Director, Medical Affairs (Europe & International)

Head, PV and Regulatory QA

Vice President, Regulatory Affairs – ELMAC

Vice President, Medical Affairs Rare Diseases

RWE Strategy Lead, Developed Brands (UK)

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