Clinical Research Associate

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

Account Manager – Health Public Affairs

Location: London
Type: Permanent

About Our Client

Our client is a specialist health and social care public affairs and communications consultancy, working at the intersection of healthcare, policy and strategic communications. Based in central London, their team supports organisations across pharmaceuticals, medical technology, diagnostics, digital health, social care and the wider health and care system to turn innovation into tangible benefits for patients and communities.

Operating within a complex, highly regulated environment, our client’s team blends health policy insight, public affairs expertise and integrated communications to help clients navigate government, Parliament and national health structures. Their work is values-led, impact-focused and designed to influence policy, accelerate adoption of innovation and build trusted stakeholder relationships.

They offer a collaborative agency culture, strong professional development and the opportunity to contribute to meaningful health and life sciences programmes that shape debate and support better outcomes for patients.

The Opportunity

This Account Manager position is ideal for a healthcare communications professional who enjoys operating at the point where life sciences, health policy and public affairs meet. You will have the chance to lead programmes that engage Parliamentarians, government departments, national health bodies and wider stakeholders, while supporting major pharmaceutical, healthtech and biotechnology clients.

You will be trusted to manage key accounts, contribute to strategy, and translate complex scientific and policy topics into clear, compelling narratives. The role offers both autonomy and support: you will work closely with senior directors, while also mentoring junior colleagues and shaping your own areas of interest within our client’s team.

Key Responsibilities

• Maintain and coordinate client programmes, ensuring strategies and activities set by directors are delivered on time and to a high standard.

• Lead engagement programmes across government, Parliament and national health bodies, articulating clients’ strategic priorities to key decision makers.

• Develop a deep understanding of client organisations and their priority therapy areas, providing strategic recommendations and solutions.

• Work alongside senior directors to develop and implement public affairs strategies and oversee the quality of all aspects of client programmes.

• Support the creation of annual client programmes and proactively identify opportunities for added value and business growth.

• Act as the main point of contact for designated clients, building strong, trusted relationships.

• Effectively manage the account team for each client, coordinating workloads and delivery.

• Produce clear, concise reports, newsletters, campaign materials and press releases.

• Engage with patient advocacy groups, charity partners and healthcare professionals on relevant programmes.

• Liaise with appropriate media outlets to support the delivery of integrated PR campaigns.

• Translate complex scientific and policy information into accessible content for external stakeholders and internal teams.

• Review daily media and political monitoring, providing timely analysis relevant to clients’ priorities.

• Contribute ideas to new business and upsell discussions, supporting the development of proposals, pitches and formal RFP responses.

• Build strong networks across clients, prospects and key stakeholders, representing our client at industry and networking events.

About You

• Agency experience working with healthcare organisations, particularly pharmaceutical, healthtech or biotechnology clients, on public affairs and integrated communications campaigns.

• Strong interest in healthcare policy, including commissioning processes, and a genuine desire to make a meaningful impact in health and social care.

• Familiarity with, and commitment to, compliance with ABPI regulations.

• Confidence in building and managing relationships with Parliamentarians, Government Ministers and senior stakeholders in life sciences and social care.

• Experience supporting internal and external communications for key clients and working with relevant media outlets.

• Comfortable working in a fast-paced, collaborative, values-driven agency environment.

• Professional yet personable communication style, able to work independently and as part of a team.

• Willingness to mentor junior colleagues, providing constructive feedback and guidance.

• Ability to explore new areas of work and champion your own professional interests within our client’s team.

Salary, Benefits & Development

• Competitive salary, aligned to your experience and responsibility level.

• 25 days’ annual leave plus UK Bank Holidays.

• Enhanced pension plan to support your long-term financial wellbeing.

• Enhanced maternity pay.

• Private healthcare provision.

• Monthly gym allowance to support your health and wellbeing.

• Outstanding training and professional development opportunities, including structured learning and on-the-job development.

How to Apply

If you bring healthcare agency experience, a strong interest in health policy and enjoy working across public affairs and communications, we would like to hear from you. Please apply with your CV and a brief summary of your relevant experience, and we will be in touch to discuss this Account Manager opportunity with our client in more detail.

Are you a seasoned pharmacometrician who enjoys solving complex development challenges, influencing strategy, and working directly with biotech and pharmaceutical clients?

An established scientific consultancy at the forefront of model-informed drug development is seeking an experienced Pharmacometrician to play a key role in delivering high-impact projects across a diverse portfolio of drug development programmes. This is a highly visible position that combines technical excellence with client engagement, commercial input, and scientific leadership.

In this role, you will lead and deliver pharmacometric analyses that directly inform critical development decisions. Working with multidisciplinary teams and external clients, you will design modelling strategies, develop quantitative frameworks, and translate complex data into actionable recommendations.

You'll have the opportunity to contribute across the full project lifecycle while helping shape new service offerings and supporting the continued growth of the business.

Key Responsibilities

• Create and apply population PK, PK/PD, exposure-response, and clinical trial simulation models

• Analyse preclinical and clinical datasets, from data preparation through to model development, validation, simulation, interpretation, and reporting

• Oversee additional modelling methodologies, including PBPK, QSP, mechanistic modelling, and NCA

• Lead client projects, providing scientific direction and strategic recommendations

• Support proposal development, project scoping, and client solution design

• Build trusted client relationships and identify opportunities for further collaboration

• Represent the organisation within the wider scientific community through conferences, publications, and industry engagement

• Stay at the forefront of developments in pharmacometrics, model-informed drug development, and regulatory science

Required Experience

• Approximately 6+ years' experience within pharma, biotech, CRO, or consulting environments

• Strong expertise in population PK, PK/PD, exposure-response modelling, and clinical trial simulation

• Advanced proficiency in NONMEM, R, or similar modelling software

• Experience leading complex modelling projects with direct stakeholder or client interaction

• Involvement in clinical development programmes and regulatory submissions/interactions

• Experience mentoring, supervising, or leading small scientific teams

QA Manager

I am partnered with a specialist and expanding pharmaceutical manufacturing business that is continuing to invest in both its people and quality function across the UK.

The business is now looking to appoint a QA Manager for one of its South East facilities in Surrey.

This is a key position within a small, fast paced manufacturing facility and an excellent opportunity to take ownership of the site wide quality systems, while helping shape quality culture and operational standards moving forward.

Acting as the local quality lead, you will oversee all site quality activities, managing a small team whilst remaining hands-on across the full spectrum of quality assurance. The position will have direct responsibility for a small team and will need to have a hands on, coaching leadership style.

This role is about far more than day-to-day operational QA. The successful individual will provide oversight of site-wide quality systems, manage priorities across multiple stakeholders, lead internal auditing activities and act as a key quality partner to both operational and leadership teams.

If you are looking for a position where you can genuinely influence quality performance across a manufacturing site, develop a team and become the recognised quality leader within the facility, please apply below or contact Mark Bux-Ryan for further information.

Key Experience:

• Strong experience within Quality Assurance in a GMP-regulated pharmaceutical environment

• Previous experience within aseptic or sterile manufacturing is required

• Leadership or management experience, either through direct line management or demonstrable team leadership responsibilities

• Strong working knowledge of quality systems and QMS oversight

• Experienced in conducting and managing internal audits

• Ability to engage effectively with a wide range of stakeholders across operations, quality and site leadership teams

• Proven ability to manage multiple priorities and deliver results in a fast-paced manufacturing environment

• Experience supporting continuous improvement and quality compliance initiatives

Additional Information:

• Site-based position

• Occasional travel to other UK sites for internal auditing activities

Quality Assurance, QA Manager, Quality Manager, GMP, Pharmaceutical Manufacturing, Aseptic, Sterile, Quality Systems, QMS, Compliance, Auditing, Internal Audit, Leadership, Quality Operations, Validation, CAPA, Documentation, Regulatory, Manufacturing, QA Lead, Site Quality.

Role Overview

Are you a seasoned Cost Engineer ready to make an impact in the world of large-scale capital projects? Join our client’s team on a two-year contract and play a pivotal role in driving the financial success of their Global Engineering initiatives. With a focus on planning, execution, and financial control, this position is a unique opportunity to collaborate across dynamic teams and add value to highly regulated industries. This office-based role offers the chance to bring your analytical expertise to life in managing complex, high-stakes projects.

About Our Client

Our client is a global leader in operations and manufacturing, dedicated to engineering excellence and innovation within highly regulated environments. With a strong commitment to collaboration and best practices, they provide a platform where experienced professionals can contribute to challenging and impactful projects, all while developing their expertise in capital engineering solutions.

About the Role

• Develop and manage project cost estimates throughout all phases, from concept to closeout.

• Establish budgets, cost baselines, and accurate cash flow forecasts for multi-faceted projects.

• Monitor expenditures, analyze financial risks, and proactively address trends and variances.

• Collaborate with project managers, engineering, procurement, and finance teams to ensure seamless cost tracking and reporting.

• Prepare executive-level cost reports and dashboards to guide critical decision-making.

• Ensure compliance with industry standards, company policies, and financial controls.

• Drive continuous improvement through cost control procedures and benchmarking analysis.

Requirements / Experience

• Minimum 5+ years of cost engineering or project controls experience.

• Expertise in capital projects within regulated industries such as pharmaceutical or biotechnology.

• Proficiency in cost management tools like SAP, Primavera P6, EcoSys, or similar platforms.

• Advanced Microsoft Excel skills, including data analysis and reporting.

Skills

• Strong analytical abilities for accurate budgeting and forecasting.

• Collaborative approach to cross-functional teamwork.

• Effective communication skills to present financial data to key stakeholders.

• Technical proficiency in cost management systems to enhance project outcomes.

Next Steps

Ready to advance your career with a pivotal role in capital project engineering? Apply now and take the first step in joining our client’s exceptional team. We look forward to hearing from you!

Senior Supply Chain Manager

We are exclusively partnered with an ambitious CDMO undergoing transformation across its operations and supply chain functions. As investment continues and the business scales, a key leadership opportunity has emerged for an experienced Senior Supply Chain Manager to play a pivotal role in driving operational excellence and cultural change.
This is far more than a functional leadership role. You'll be at the centre of a business-wide transformation, helping to modernise planning processes, introduce new ways of working, and build a highly engaged team capable of supporting future growth.
What you'll be doing
This role has three key areas of focus:
• Leading the development and implementation of a new scheduling and planning tool.
• Driving engagement, adoption and cultural change across the planning function.
• Taking ownership of both Warehouse Logistics and Production Planning operations, ensuring the smooth execution of day-to-day activities while building for the future.
Success in this position will require someone who is equally comfortable operating strategically and spending time on the shop floor understanding the realities of the operation. You'll lead from the front, bringing teams with you through change while maintaining a relentless focus on service, efficiency and continuous improvement.
What we're looking for
• Supply chain leadership experience within pharmaceuticals, food manufacturing or FMCG.
• Strong background in production planning and scheduling.
• Proven experience leading transformation or change initiatives.
• Demonstrated success managing and developing teams.
• Ability to drive engagement, influence stakeholders and create buy-in across functions.
• A hands-on leadership style with a genuine understanding of operational environments.
• GMP experience would be advantageous but is not essential.
Why consider this opportunity?
• Play a key role in a business undergoing significant growth and investment.
• Lead a high-profile transformation programme with visible impact.
• Shape the future direction of critical supply chain functions.
• Join a company where your leadership and ideas will directly influence success.
• Be part of a collaborative, ambitious leadership team committed to building a best-in-class operation.

For further details, please contact Mark Bux-Ryan
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