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Senior Regulatory Consultant - Small Molecule Registration (Lead)

United Kingdom
GBP 0

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

Medical Education Manager

United Kingdom
GBP 40000 - 50000

Medical Education Manager

Location: UK (Remote with in-person event commitments)

Position type: Permanent

About Our Client

Our client is a specialist healthcare communications organisation focused on delivering evidence-based news and independent medical education for medical specialists. Operating within the UK pharmaceutical and healthcare ecosystem, they create trusted content, collaborate closely with expert clinicians, and run both digital and in-person education initiatives for defined specialist audiences. Their environment is collaborative, fast-paced and well suited to someone who enjoys combining scientific rigour with practical delivery of impactful educational programmes.

The Opportunity

This Medical Education Manager role gives you the chance to shape independent medical education that genuinely supports clinical practice across multiple therapy areas. You will sit at the intersection of scientific content, adult learning, stakeholder engagement and hands-on project delivery. You will work remotely while building strong relationships with senior clinicians, pharma partners and internal teams, taking ownership of programmes from strategic planning through to execution and evaluation.

Key Responsibilities

• Lead the delivery and execution of independent medical education activities, including webinars, in-person meetings and other learning formats.

• Support the Scientific and Education Director in defining the strategic direction for independent medical education programmes.

• Contribute to annual education planning, including topic selection and audience prioritisation.

• Identify educational needs through needs assessments, scientific insights and stakeholder engagement.

• Horizon scan for new developments in therapeutic areas that may require targeted education.

• Build and maintain effective relationships with key opinion leaders, faculty members and professional societies.

• Analyse programme outcomes using quantitative and qualitative data, generating insights to refine future initiatives.

• Manage end-to-end delivery of independent medical education webinars, including faculty coordination, asset management, live execution and post-event reporting.

• Manage end-to-end delivery of in-person events, including venue identification and booking, logistics and liaison with all relevant stakeholders, including industry partners.

• Identify, approach, brief and coordinate expert KOLs to participate in webinars, podcasts and events.

• Provide content development support to expert participants to ensure scientific clarity and educational impact.

• Lead complex cross-functional educational projects from planning through to execution, managing timelines, budgets, vendors and contracts.

• Write and edit run sheets and scripts for live webinars and events.

• Develop written materials to support medical education, including educational content and learning objectives based on adult learning principles.

• Contribute to proposals and grant applications to secure funding for independent education programmes.

• Create materials to promote educational events, such as email copy and website text.

• Support the recording and editing of content such as webinars, videos and podcasts.

About You

• BSc in medical or related sciences (or equivalent scientific degree).

• Experience delivering projects for pharmaceutical companies or medical communications agencies in the UK.

• Solid understanding of medical science and pharmaceutical marketing/communications.

• Awareness of adult learning principles and how to translate them into effective educational formats.

• Proven medical writing experience, ideally within MedComms/MedEd.

• Demonstrable project management experience, including time and budget management.

• Training in the ABPI Code and confidence working within regulatory and compliance frameworks.

• Experience working with KOLs and external faculty, including briefing and relationship management.

• Strong interpersonal skills, with the ability to communicate clearly and respectfully with clinicians, pharma stakeholders and internal colleagues.

• Comfortable managing a complex workload, problem solving and taking initiative to move projects forward.

• High level of computer literacy, including Microsoft Office and other relevant systems.

• Flexible, solutions-focused and comfortable working within a small, agile business with a collaborative, “can do” mindset.

Who You’ll Work With

• Internally, you will collaborate closely with sales and marketing, partner content teams, the medical education team and editorial colleagues to deliver cohesive programmes.

• Externally, you will engage with medical and marketing personnel in pharmaceutical, biotech and medical device organisations, as well as PR and creative agencies.

• You will also work directly with senior clinicians and healthcare professionals who contribute to educational and commercial content projects.

What This Role Offers You

• The opportunity to directly influence independent medical education that supports real-world clinical decision-making.

• High levels of ownership across programmes, from strategy and design through to delivery and evaluation.

• Regular interaction with leading clinicians, faculty and industry stakeholders.

• A remote-working setup combined with the variety of in-person meetings and events.

• A collaborative culture where your scientific expertise, creativity and initiative are valued within our client’s team.

How to Apply

If you are an experienced MedEd or MedComms professional with a strong scientific background, proven project delivery experience in the UK pharma environment and confidence working with KOLs, we would like to hear from you. Please submit your CV to be considered and we will be in touch to discuss this Medical Education Manager position in more detail.

Senior Regulatory CMC Project Lead - Interim

United Kingdom
GBP 0

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

Senior Director Engineering & Maintenance

United States
USD 240000 - 250000

Senior Director, Engineering & Maintenance

We are partnered exclusively to appoint a Senior Director of Engineering & Maintenance to lead a multi-site pharmaceutical manufacturing organisation through an exciting period of growth, investment and operational improvement.

With responsibility for Engineering, Maintenance, Reliability, Automation, Validation and Capital Projects, this role will focus on strengthening leadership capability, driving engineering performance and ensuring the organisation is equipped to support future expansion.

Leading a team of functional heads and an organisation of 50+ technical professionals, you will balance strategic priorities with operational execution, identifying risks, developing talent and delivering sustainable improvements across multiple manufacturing facilities.

Key Responsibilities

Provide leadership across Engineering, Maintenance, Reliability, Automation and Validation
Drive engineering strategy and site improvement initiatives
Develop and coach technical leaders across the organisation
Support major capital investment and expansion programmes
Strengthen reliability, compliance and risk management practices
Build a culture of accountability, engagement and continuous improvement
Identify capability gaps and implement development plans


Desired Experience

Significant engineering leadership experience within a regulated pharmaceutical manufacturing environment – drug product or drug substance. Sterile/Aseptic would be advantageous.
Must bring previous Director or Senior Director level responsibility – demonstrating exposure to different environments and challenges.
Experience leading multi-disciplinary engineering teams
Strong understanding of maintenance, reliability and validation principles
Background within pharmaceutical, biotech, sterile, aseptic or other cleanroom manufacturing environments
Demonstrated success developing teams and future leaders
Experience supporting growth, transformation and capital projects


Leadership Profile

We're looking for a leader who knows how to build high-performing teams. Someone who can coach, mentor and develop others, whilst creating clear expectations, accountability and engagement across the organisation.

This is an opportunity to join a business investing heavily in its operations and people, offering significant scope to shape the engineering function and make a lasting impact on future growth.

Engineering, maintenance, validation, capex, project, pharmaceutical, manufacturing, reliability, automation, continuous, improvement


Production Manager

United Kingdom
GBP 50000 - 55000

Production Manager

Location: Woking

An exciting career advancement awaits you in the dynamic pharmaceutical industry. You'll spearhead aseptic pharmaceutical production, directly impacting the delivery of high-class patient care. This role offers immersive hands-on experience in overseeing production, guiding teams, and maintaining compliance with rigorous regulatory standards like GMP. With plenty of opportunity for training and growth, you'll refine your expertise in crucial areas such as team leadership and regulatory adherence. Join a thriving team and take part in pioneering innovation, achieving excellence, and elevating healthcare standards.

Responsibilities:
• Manage production of aseptic pharmaceutical products.
• Lead and train the production team, ensuring adherence to GMP standards.
• Coordinate staff schedules and oversee maintenance of production equipment.
• Assist in the development and management of quality systems.
• Participate in the management team at a strategic level.


Experience:
• Minimum 3 years' experience in pharmaceutical production
• Managerial or supervisory experience is essential.
• Equipment validation experience is an advantage but not essential.
• Any prior experience with sterile pharmaceuticals is an advantage.

Skills/Attributes:
• Proficient in Microsoft Office.
• Strong communication and organizational skills.
• Self-motivated, detail-oriented, and proactive.

Key Words:
Aseptic, sterile, production, manufacturing, GMP, manager, managerial, team leader, lead, supervisor, section, team, training, supervision, coaching, department, Cgmp, pharmaceutical, biopharmaceutical, pharma, biopharma, vaccine, injectables, filling, compounding.

ERP Specialist (Sage)

United Kingdom
GBP 80000

ERP Specialist (Sage)

Are you an experienced ERP professional with a strong track record working with Sage (Manufacturing, Supply Chain, Finance, Quality, HR and IT), looking to take ownership of meaningful systems work and support a growing technology landscape? Our client is seeking an ERP Specialist to help shape and optimise their use of Sage within a hybrid working environment 2 - 3 days onsite based in London.

The Role

This role will work closely with stakeholders across Manufacturing, Supply Chain, Finance, Quality, HR and IT to deliver ERP improvements, manage system changes, support vendors, and ensure business-critical processes run effectively.

Key Requirements

  • 2-5 years' experience supporting or developing Sage ERP solutions

  • Experience within manufacturing, pharmaceutical, life sciences or other regulated environments

  • Strong understanding of ERP processes across operations, supply chain and finance

  • Experience working with business users, IT teams and third-party vendors

  • Knowledge of ERP reporting tools and Power BI

  • Must be fluent in English and French

  • Interest in developing future SAP capabilities as part of a long-term ERP transformation programme

What's on Offer?

  • Opportunity to work across multiple European manufacturing sites

  • Exposure to large-scale ERP transformation initiatives

  • Clear pathway to develop SAP expertise

  • Collaborative international environment within a growing life sciences business

How to Apply

If you are an ERP Specialist with Sage experience and you are looking for a permanent, hybrid role in London where you can contribute directly to how an organisation uses its core systems, we would like to hear from you. Apply today to explore this opportunity further and learn more about joining our client’s team.

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RBW immediately had an impact from a recruiting perspective but also as a wonderful partner to our business stakeholders and the external market. 

They use their key strengths of kindness and authenticity to build relationships across the board. Not only are they able to understand the business need and identify top talent in the competitive cell/gene therapy market, they are also good humans; the high bar they set for themselves motivates them to do amazing work and do what is right for people.

Head of TA

Small Biotech

Our business is CDMO working on biopharmaceutical development and manufacturing. In the time that RBW has been supporting us, they have been nothing but amazing.  They have gotten to know our business inside and out, and whether it is a permanent position or a contractor needed for any of our roles, ranging from GMP Assistants, Operators, Production Leaders, Validation, QA, QC, they have always spent time not just with us from a recruitment needs but with every manager to get to know exactly what we are looking for, even if the same roles came up time and time again.

HR Business Partner

Global CDMO

RBW have been instrumental to our successful transformation. Always bringing us a smile they are highly creative and there is no challenge they can’t overcome. Their emotional intelligence is outstanding, and they have an authentic, warm personal charm which is infectious. Their wide span of knowledge and experience can be consistently relied on, and they are a valued partner that we take true delight in working with.

HR Director

Global Medcomms Agency