Immunohistochemistry Scientist

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

Programme Executive (IME/CME)

Are you looking to develop your career in medical communications and medical education, working on impactful programmes that support clinicians around the world? Our client is seeking a Programme Executive to join their team on a permanent basis, supporting the delivery of both live and enduring (on-demand) educational activities.

About Our Client

Our client is a medical education organisation with a strong focus on IME and CME activities delivered via webinars, virtual events and on-demand content. Operating in a fast-paced, growth-orientated environment, our client’s team collaborates closely across functions to deliver high-quality educational programmes for healthcare professionals. You will be joining a business that values rigorous delivery standards, clear communication and a proactive approach to improving processes and ways of working.

The Role: Programme Executive 

As Programme Executive, you will support the planning, coordination and delivery of medical education programmes across live and enduring formats. Working alongside experienced colleagues, you will manage day-to-day project administration, track timelines, coordinate materials and help ensure every activity is delivered smoothly and to a consistently high standard. This role is ideal for someone who enjoys organisation, stakeholder communication and contributing to meaningful work in MedEd.

What You Will Be Doing

• Support the delivery of on-demand educational programmes, ensuring activities are produced and released on schedule.

• Assist with creating and maintaining project timelines, monitoring progress against agreed plans and flagging risks or issues as they arise.

• Coordinate programme materials with internal colleagues and external stakeholders to ensure content is accurate, complete and up to date.

• Upload, organise and maintain educational content within the platform used by our client’s team, ensuring information is clearly presented.

• Support the planning and execution of webinars and virtual educational events, including scheduling, platform setup and event logistics.

• Assist in transitioning live content into enduring educational resources, helping to maximise the impact and reach of each activity.

• Coordinate communications with faculty, speakers and moderators, making sure they are well informed and prepared at every stage.

• Track the receipt of presentations, recordings, disclosures and supporting materials, ensuring all deliverables are received on time and meet required standards.

• Work closely with Programme Managers and cross-functional teams to keep project trackers, timelines and documentation accurate and current.

• Use internal systems and the MedEd platform to support programme delivery, including creating simple visual assets using Canva where needed.

• Identify opportunities to streamline processes and improve ways of working, contributing to continuous improvement across the team.

• Provide general operational support across the business and play an active role in a collaborative, delivery-focused environment.

About You

• Previous experience within a medical communications agency, ideally supporting programme or account delivery.

• Excellent organisational skills with strong attention to detail and the ability to keep multiple activities on track simultaneously.

• Confident written and verbal communication skills, with the ability to liaise professionally with internal teams and external faculty.

• A proactive, can-do attitude and a genuine willingness to learn, adapt and step in where needed.

• Comfortable working in a fast-paced, high-velocity environment where priorities can shift and quality standards remain high.

• A background in science or life sciences is beneficial but not essential; an interest in healthcare and medical education is highly valued.

What’s In It For You

• Day-to-day exposure to webinars, virtual events and on-demand content, giving you a broad skill set.

• Close collaboration with experienced Programme Managers and cross-functional teams who will support your development.

• A role where your organisation, initiative and attention to detail directly contribute to closing healthcare gaps and improving education for clinicians.

• The chance to grow as the business evolves, expanding your responsibilities and shaping your career within medical communications.

How To Apply

If you have experience in medical communications and are keen to build your career in programme delivery within IME/CME, we would like to hear from you. Please submit your CV, outlining your relevant experience and motivation for the role, and a consultant will be in touch to discuss this opportunity with our client’s team.

Clinical Research Associate (Senior CRA / Principal CRA) – Remote, UK

Location: Fully remote with travel across England

Position type: Permanent

About Our Client

Our client is a well-established clinical research organisation operating within highly regulated environments, supporting complex, international clinical trials. Working across multiple therapeutic areas and trial phases, they focus on high-quality monitoring, balanced performance expectations and clear career pathways for their clinical operations professionals.

Our client’s team is known for promoting from within, supporting long-term careers in clinical research and offering flexible working arrangements that respect work-life balance. You will be joining a collaborative group of CRAs, study managers and operational specialists who share knowledge and support each other across remote locations.

The Opportunity

This is a permanent, fully remote Clinical Research Associate position, open at CRA II, Senior CRA or Principal CRA level depending on your experience and skill set. You will work across a variety of clinical trials and phases without being limited to specific therapeutic areas, giving you broad exposure and the chance to deepen your monitoring expertise.

The role offers a visible pathway for progression, with genuine potential to move quickly through levels based on performance and capability. You will benefit from balanced KPIs, realistic expectations around travel and a supportive structure that focuses on your development rather than simply maximising visit numbers.

Key Responsibilities

• Conduct independent on-site monitoring visits across England

• Perform all aspects of routine monitoring activities in line with protocols, SOPs and regulatory requirements across various trial phases.

• Build and maintain strong relationships with site staff to support study conduct, data quality and patient safety.

• Document monitoring activities comprehensively and ensure timely follow-up on action items.

• Collaborate closely with project teams, contributing to study management discussions and resolving site-related issues.

• Demonstrate flexibility around travel and site allocation, understanding that locations may vary according to business needs.

What Makes This Role Attractive

• Clear and visible career progression, with defined levels from CRA II through Senior CRA to Principal CRA, and examples of rapid promotion where merited.

• Balanced KPIs that allow you to focus on quality, development and long-term growth rather than only meeting high visit targets.

• Genuine work-life balance, supported by remote working and thoughtful study allocation.

• Near-site incentives and an approach to site allocation that aims to keep you predominantly within reasonable travelling distance, while recognising that some longer trips may be required.

• Access to peer and buddy programmes, offering mentoring, support and guidance from more experienced colleagues.

• Opportunities to progress into other suitable career pathways, depending on your interests and strengths.

Skills & Experience Required

• Strong, independent on-site monitoring experience in clinical trials,

• For Principal CRA / Lead CRA consideration, usually 6–8 years’ CRA experience, with a proven track record of handling complex studies and responsibilities.

• Experience across any therapeutic areas and clinical trial phases – there is no requirement for specific indication expertise.

• A valid driving licence and willingness to travel regularly for site visits.

• Life Sciences degree or relevant experience

• Right to work in the UK is essential; our client is unable to offer visa sponsorship.

Is This Role Right For You?

This position will suit you if you are an experienced CRA who values structured progression, realistic monitoring expectations and genuine work-life balance. If you enjoy independent on-site work, want to broaden your exposure across different studies and phases, and are looking for a remote role that still offers strong team connection and support, this could be an excellent next step.

How to Apply

If you meet the criteria outlined and would like to be considered for a CRA II, Senior CRA or Principal CRA level position, please submit your CV. We will review your experience, discuss your career ambitions and guide you through the next steps with our client.