Pharma

Senior Regulatory CMC Consultant - Biologics / ADC Programmes
Global MAA & BLA Strategy | Regulatory CMC Leadership | Contract

We're supporting a global pharmaceutical organisation as they strengthen Regulatory CMC leadership across a high-profile biologic Antibody-Drug Conjugate (ADC) programme approaching major regulatory milestones.
This opportunity will suit an experienced Regulatory CMC professional who combines strategic leadership with hands-on execution and has a proven track record leading Module 3 activities for biologic MAA and/or BLA submissions. Operating within an international matrix environment, you will partner closely with Regulatory Affairs, CMC Development, Quality, Manufacturing and Technical Writing teams to drive global registration readiness and submission success.

The Opportunity
• Lead the global Regulatory CMC strategy for a late-stage biologic ADC programme intended for worldwide registration.
• Provide strategic guidance and oversight for global MAA and BLA preparation, submission and review activities.
• Drive alignment between CMC development activities, regulatory strategy and wider programme objectives.
• Lead cross-functional regulatory planning, governance and risk management across multiple internal and external stakeholders.
• Act as a senior Regulatory CMC advisor supporting health authority interactions across major global markets.
Key Responsibilities
• Develop and execute global Regulatory CMC strategies for complex biologic products.
• Lead CMC aspects of MAA and/or BLA submissions, ensuring quality, compliance and timely delivery.
• Review and finalise Module 3 documentation, ensuring scientific robustness and regulatory suitability.
• Lead preparation for FDA, EMA and other global health authority interactions, including briefing documents and regulatory responses.
• Provide strategic input on regulatory positioning, risk mitigation and agency engagement plans.
• Coordinate cross-functional activities across Regulatory Affairs, CMC, Technical Operations, Quality and Manufacturing.
• Support responses to health authority questions, deficiency letters and post-submission activities.
• Ensure compliance with evolving global regulations, guidelines and CMC expectations for biologics and ADC products.
• Drive stakeholder alignment and delivery across a complex global matrix structure.

Consultant Profile
We are particularly interested in Regulatory CMC professionals who can demonstrate:
• Extensive Regulatory Affairs CMC experience within biotechnology and/or pharmaceutical environments.
• Proven hands-on leadership of Module 3 activities supporting biologic MAA and/or BLA submissions.
• Strong expertise across biologics, including complex products and advanced therapeutics.
• Experience developing and implementing global Regulatory CMC strategies through late-stage development and registration.
• Deep understanding of FDA, EMA, ICH and global CMC regulatory requirements.
• Experience preparing and supporting health authority interactions, scientific advice meetings and regulatory negotiations.
• Strong stakeholder management and matrix leadership capability.
• The ability to operate strategically whilst remaining hands-on when required.
• Excellent communication, collaboration and problem-solving skills.

Cmc, regulatory, affairs, ADC, antibody, drug, conjugate, biologics, large, molecule, submission, BLA, MAA, consultant, interim, freelance

Senior Regulatory Consultant – Small Molecule Registration (Lead)

Late-Stage Small Molecule | Global Regulatory Strategy | MAA Preparation

A rare opportunity has arisen for an experienced Regulatory CMC leader to take ownership of a high-profile late-stage small molecule programme approaching Marketing Authorisation submission.

This role sits at the heart of a global development team and offers the chance to shape CMC regulatory strategy for a key asset at one of the most exciting stages of the product lifecycle.

You'll be the driving force behind the global CMC regulatory roadmap, partnering with technical development, manufacturing, quality, supply chain and regulatory stakeholders to ensure successful delivery of a complex registration programme.

The Opportunity

This is more than a traditional Regulatory Affairs role.

You'll act as the strategic CMC lead for a late-stage development asset, defining and executing global regulatory strategy, preparing for key Health Authority interactions, identifying risks early, and ensuring a high-quality CMC dossier is delivered on time.

Working within a highly collaborative international environment, you'll influence critical development decisions, support accelerated development pathways and play a key role in bringing an important new medicine to patients worldwide.

What You'll Be Doing

Lead the global Regulatory CMC strategy for a late-stage small molecule programme.
Drive preparation and delivery of the CMC components of a Marketing Authorisation Application.
Act as the CMC regulatory lead for Health Authority interactions, including briefing package development and regulatory responses.
Partner with Technical Development, Quality, Manufacturing and Supply Chain teams to align development activities with regulatory expectations.
Provide strategic direction to CMC dossier preparation and technical writing activities.
Identify regulatory risks, perform gap assessments and develop mitigation strategies.
Support global submissions across major and emerging markets.
Represent Regulatory CMC within cross-functional project and governance teams.

What We're Looking For

Significant experience within Regulatory Affairs CMC.
Proven involvement in late-stage development programmes and Marketing Authorisation submissions.
Strong understanding of small molecule development and registration activities.
Experience developing and implementing global CMC regulatory strategies.
Strong knowledge of FDA, EMA and ICH requirements.
Exposure to international markets including China, Japan, Canada or other global regions would be advantageous.
Experience authoring or reviewing Module 3 documentation and managing complex CMC submissions.
Confident communicator with the ability to influence stakeholders across multiple functions and geographies.
Strong project leadership, problem-solving and risk management skills.

Regulatory, RA, affairs, CMC, small, molecule, late, stage, phase, development, module, matrix, leadership, consultant, freelance, interim, lead, manager, strategy, registration

Senior Regulatory CMC Project Lead - Interim

Late-Stage Small Molecule Development | Global Regulatory Strategy | MAA Preparation

6 months – renewable

Remote

If based in UK, Outside IR35

Are you a seasoned Regulatory CMC professional looking to take ownership of a high-profile late-stage asset approaching registration?

We're supporting an innovative global pharmaceutical organisation seeking a Senior Regulatory CMC Project Lead to drive regulatory strategy for a key small molecule programme as it advances towards Marketing Authorisation submission.

This is a highly visible position where you'll play a central role in shaping global CMC regulatory strategy, influencing critical development decisions, and working alongside senior scientific, quality, supply chain and regulatory leaders across multiple geographies.

The Opportunity

You'll become the strategic Regulatory CMC lead for a late-stage small molecule asset, taking ownership of the global CMC regulatory roadmap and ensuring successful preparation and delivery of the registration dossier.

Working at the heart of a complex global development programme, you'll collaborate with cross-functional teams, lead agency interaction strategies, manage regulatory risk, and help accelerate the path to patients through innovative and pragmatic regulatory approaches.

This is an excellent opportunity for someone who enjoys combining technical CMC expertise with strategic leadership, stakeholder engagement, and regulatory project delivery.

What We're Looking For

10+ years' experience within Regulatory Affairs CMC – focused specifically on small molecule late stage development.
Proven experience leading the CMC components of global Marketing Authorisation submissions.
Strong understanding of late-stage development and registration activities for small molecule products.
Experience developing and executing global regulatory strategies.
Deep knowledge of FDA, EMA and ICH regulatory requirements.
Exposure to international markets such as China, Japan, Brazil and Canada would be highly advantageous.
Demonstrated success working within complex, cross-functional global development teams.
Excellent project leadership, communication and stakeholder management skills.
Strong analytical, problem-solving and risk management capabilities.
Life Sciences degree required; MSc, PharmD or PhD preferred.

CMC, regulatory, MAA, late, phase, three, development, small, molecule, API, BLA, stage, interim, freelance, contract

Production Technician

📍 Wimbledon, Surrey

🕒 Monday to Friday | 6:30am – 3:00pm

Are you an experienced Production professional looking for your next opportunity within a quality-focused manufacturing environment?

We are recruiting for a Production Operator to join a well-established and growing business in Wimbledon. This role would suit someone with previous experience working under GMP regulations who enjoys hands-on manufacturing work and takes pride in maintaining high standards of quality and compliance.

The Role

As part of the production team, you will play a key role in ensuring products are manufactured safely, efficiently, and in line with company procedures and quality requirements.

Key Duties

• Carry out production activities in accordance with GMP and company procedures

• Operate manufacturing and processing equipment safely and effectively

• Follow detailed work instructions and standard operating procedures (SOPs)

• Complete production documentation and batch records accurately

• Conduct routine weighing, mixing, packing, assembly, or processing tasks

• Maintain high standards of housekeeping, cleanliness, and workplace safety

• Support quality, compliance, and continuous improvement initiatives

About You

We are keen to speak with candidates who have:

• Previous experience within a production, assembly or manufacturing environment

• Exposure to industries such as pharmaceuticals, food production, cosmetics, medical devices, or chemicals

• Experience operating production or packaging machinery

• A reliable and positive attitude with good team-working skills

What's in It for You?

• Regular day shifts with no weekend working

• Stable Monday to Friday schedule

• Full training and ongoing development support

• Friendly, collaborative working environment

• Opportunity to join a growing manufacturing business

• Long-term career prospects within a regulated production setting

If you have manufacturing experience and are looking to join a company that values quality, teamwork, and continuous improvement, we'd love to hear from you.

Apply now to find out more.

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.

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