Pharma

Senior Regulatory CMC Consultant – ADC Linker-Payload Drug Substance

6-Month Contract (Renewable) Remote – Europe

Opportunity

An exciting opportunity has arisen for an experienced Senior Regulatory CMC Consultant to support a late-stage oncology programme focused on Antibody Drug Conjugates (ADCs). This is a high-impact consultancy position where you will lead the global regulatory strategy for the linker-payload drug substance component of an innovative ADC programme as it progresses towards major regulatory submissions.

Working within a collaborative Regulatory CMC environment, you will play a critical role in ensuring that the drug substance regulatory package is submission-ready for both European and US health authorities.

This is a fully remote position within Europe offered initially as a 6-month contract with strong likelihood of extension.

Key Responsibilities

Lead Regulatory CMC strategy for the ADC linker-payload drug substance
Provide strategic guidance for global regulatory submissions, including FDA and EMA marketing applications
Drive development and review of Module 3 drug substance documentation
Ensure compliance with current ICH, FDA and EMA regulatory expectations
Support health authority interactions and responses to regulatory questions
Collaborate extensively with CMC, Analytical Development, Process Development, Quality and Manufacturing teams
Contribute to regulatory risk assessments and mitigation strategies
Provide expert advice on drug substance control strategies, specifications, characterisation and stability packages
Support programme teams through critical development and submission milestones

Candidate Profile

Essential Experience

Approximately 10 years or more of Regulatory CMC experience
Strong background in drug substance development
Proven experience leading CMC drug substance aspects of global regulatory submissions
Deep understanding of Module 3 Quality documentation
Excellent working knowledge of ICH, FDA and EMA regulatory requirements
Experience supporting late-stage development or registration programmes

Highly Desirable

Antibody Drug Conjugate (ADC) experience
Linker-payload development experience
Highly potent API (HPAPI) experience
Bioconjugate or complex biologics experience
Experience supporting Marketing Authorisation Applications (MAA), BLAs or equivalent global filings

EU Rate - €500-€600 p/day

Regulatory, CMC, ADC, drug, substance, submission, antibody, conjugate, BLA, MAA, marketing, authorisation, FDA, EMA, module

Study Monitoring Lead
Department: Global Clinical Operations

Position Summary
The Study Monitoring Lead is responsible for the operational oversight of global clinical trials, ensuring studies are executed in accordance with protocol, timelines, ICH-GCP, regulatory requirements, and company SOPs. The SML oversees study feasibility, site management, monitoring activities, and CRO/vendor performance while partnering with cross-functional teams to drive successful study execution.

Responsibilities

• Lead study feasibility activities, evaluating country and site capabilities, patient access, and operational readiness.

• Partner with the Clinical Study Manager, Clinical Study Physician, and CROs to support country and site selection.

• Oversee site activation activities, including regulatory documentation, contracts, investigational product supply, laboratory kits, and other start-up requirements.

• Monitor site activation, enrollment, protocol compliance, and data quality.

• Prepare, review, or approve Monitoring Plans, Laboratory Manuals, patient-facing materials, and other operational study documents.

• Oversee CRO and vendor performance related to site management and monitoring.

• Support training for CRO Clinical Trial Leads, CRAs, and investigative sites.

• Oversee remote and on-site monitoring activities, ensuring timely visit completion, issue resolution, and follow-up.

• Conduct sponsor co-monitoring visits and perform monitoring or co-monitoring activities as needed.

• Track study metrics, including site activation, enrollment, monitoring visits, protocol deviations, and overall study progress.

• Oversee biological sample tracking and investigational product management with study stakeholders.

• Collaborate with Clinical Operations, Data Management, Medical, Safety, Regulatory, Clinical Supply, CROs, vendors, investigators, and study sites to ensure efficient study execution.

• Identify and resolve operational risks, escalating issues when appropriate.

• Ensure compliance with study protocols, ICH-GCP, regulatory requirements, and company SOPs while supporting inspection readiness.

Qualifications

• Master's degree in Life Sciences or a related field.

• 5+ years of clinical operations experience, including 3+ years monitoring oncology studies as a CRA or comparable site management role.

• Experience with study feasibility, site selection, site activation, monitoring oversight, and CRO/vendor management.

• Strong knowledge of ICH-GCP, global clinical trial regulations, and inspection readiness.

• Excellent communication, collaboration, organizational, analytical, and problem-solving skills.

• Ability to travel internationally as required.

Laboratory Validation Officer / Analytical Chemist

Location: South London

As part of a significant operational expansion we are delighted to be exclusively partnering with a market leading global brand and supporting the hire of a new Laboratory Validation Officer.

The successful hire will focus predominantly on method validation activities from bench to HPLC. There may be the need for some degree of method development.

Working in a small team this role must have independent and “can do” focus.

The opportunities in the business for development and progression are strong and they welcome a proactive and ambitious attitude.

For further details please contact Mark Bux-Ryan

Key experience

- Previous experience in method validation of HPLC

- Pharmaceutical (or healthcare/nutraceutical) GMP experience

- Any method development experience is advantageous

- Problem solving mindset with ability to work independently

laboratory, validation, method, HPLC, development, transfer, chromatography, liquid, pharmaceutical, research, analytical, scientist

QA / QMS Officer

Location: South London

As part of a significant operational expansion and investment into the Quality team, we are delighted to be exclusively partnering with a market leading global brand and supporting the hire of a new QA Officer, with a systems focus.

The successful hire will work within the QMS team and will focus their time around managing and conducting internal audits, as well as writing change controls, amongst other activities. Given the size of the team and the expansion of operations, the need for working quickly and confidently across all levels is critical.

The opportunities in the business for development and progression are strong and they welcome a proactive and ambitious attitude.

For further details please contact Mark Bux-Ryan.

Key experience

- Previous experience in managing quality systems / QMS

- Knowledge of QPULSE is an advantage

- Pharmaceutical (or healthcare/nutraceutical) or food manufacturing GMP experience essential

- Must have experience in managing and writing change controls

- Internal auditing experience essential

Quality, management, system, QMS, change, control, deviation, CAPA, audit, internal, lead, SOP, QA, officer, specialist, auditor

Senior QA Officer

Location: South London

We are exclusively supporting one of our longest standing clients in a significant expansion through the course of 2026.

As part of this, they are appointing a new position of Senior Quality Assurance Officer within their operational quality team on site in South London.

This person will strike the balance in hands on quality activities, as well as performing a deputy in absence of the Team Leader. As well as the usual operational quality activities such as batch release, deviation management and change control implementation, this person will need to take a lead on process ownership of investigation management and risk assessments.

If you enjoy working in a flat structured team, with broad responsibilities and a genuine opportunity for development, this could be the ideal career move.

This is a fully site based role in South London.

For further details, please contact Mark Bux-Ryan.

What you need to bring:

• Established QA experience within a GMP setting – ideally pharmaceuticals, although food manufacturing will be considered.

• Evidenced experienced of independent process ownership within QA activities – ideally investigation and risk assessment management

• Excellent stakeholder management skills

• Flexible and adaptable approach

Quality, QA, officer, investigation, risk, deviation, management, CAPA, change, control, batch, review, release, GMP, manufacturing, food, supplement, pharmaceutical, nutraceutical, SOP, senior, specialist, system, operation

Improvement Maintenance Engineer
Exciting Opportunity to Launch Your Engineering Career in Healthcare Manufacturing
Are you an engineer who enjoys getting hands-on with equipment while also being involved in continuous improvement projects? Do you have a passion for problem-solving and a desire to make things better?
We're looking for a motivated Improvement Maintenance Engineer to join a growing healthcare manufacturing business operating within a highly regulated GMP environment. This is a fantastic opportunity for someone early in their engineering career who wants broad exposure across maintenance, engineering projects, compliance, and continuous improvement.
You'll play a key role in keeping manufacturing equipment operating efficiently through planned and reactive maintenance activities, while also helping to identify and implement improvements that enhance reliability, performance, and productivity.
This isn't just a maintenance role. We're looking for someone with curiosity, initiative, and a genuine desire to learn, challenge existing processes, and contribute to the future development of the site.
What You'll Be Doing
• Supporting planned preventative and reactive maintenance activities across manufacturing equipment.
• Diagnosing and resolving mechanical and electrical faults.
• Assisting with equipment upgrades, modifications, and improvement projects.
• Identifying opportunities to improve equipment reliability and manufacturing performance.
• Participating in root cause investigations and implementing corrective actions.
• Developing and maintaining SOPs, maintenance records, and technical documentation.
• Ensuring maintenance activities are completed in line with GMP and compliance requirements.
• Maintaining accurate audit trails and supporting inspection readiness.
• Working closely with Production, Quality, and Engineering teams to support operational excellence.
What We're Looking For
• Engineering Degree, HNC/HND, apprenticeship qualification, or equivalent in Mechanical, Electrical, or a related Engineering discipline.
• A genuine interest in maintenance, manufacturing, and engineering problem-solving.
• A proactive mindset with the confidence to suggest and implement improvements.
• Strong attention to detail and an appreciation for working within a regulated environment.
• Comfortable balancing practical hands-on engineering work with documentation responsibilities.
• Excellent communication and organisational skills.
• A willingness to learn, develop, and undertake training.
Desirable Experience
• Previous engineering, maintenance, manufacturing, or technical experience.
• Exposure to GMP, pharmaceutical, medical device, healthcare, food, or other regulated manufacturing environments.
• Experience working with both mechanical and electrical systems.
• Knowledge of continuous improvement methodologies.
Why Apply?
• Excellent entry point into a highly regulated healthcare manufacturing environment.
• Opportunity to develop both mechanical and electrical engineering skills.
• Exposure to continuous improvement and engineering project work.
• Structured training and development from experienced engineers.
• Chance to build a long-term career within a growing and innovative organisation.
• A varied role where no two days are the same.
If you're an ambitious engineer looking for an opportunity to develop your technical skills, make a real impact, and build a rewarding career in industry, we'd love to hear from you.