Senior CMC Regulatory Consultant (Small Molecules)

We’ve partnered with a fast‑growing and genuinely disruptive life science tools company that is transforming how laboratories operate. Their technology enables researchers and biopharma teams to automate complex workflows, improve data quality, and scale discovery and development activities more efficiently.

Following strong global momentum and increasing demand from US customers, the company has created this new Business Development Manager role to accelerate growth across the US.

This is a highly visible position, ideal for someone who thrives in a hands‑on, commercial role and wants to play a central part in expanding adoption of advanced lab automation solutions.

 

The Role

As Business Development Manager, you will be responsible for driving new business and expanding strategic accounts across your assigned region.

This is a broad, impactful role that combines direct sales execution with market development, positioning the company’s automation platforms with leading biopharma, biotech, CRO, and advanced research laboratories.

 

Key responsibilities include:

• Owning and executing the regional business development strategy for lab automation instrumentation
• Identifying, qualifying, and winning new customers while expanding usage within existing accounts
• Building trusted relationships with scientific, automation, and operational stakeholders
• Working closely with applications, field support, and product teams to deliver a strong customer experience
• Feeding market intelligence back into marketing and product management to influence positioning and roadmap
• Representing the company at key customer meetings, workshops, and industry events

 

Your Profile

• Proven success selling lab automation systems, laboratory instrumentation, or complex capital equipment into life science research or biopharma environments
• Comfortable driving the full sales cycle, from prospecting through to close
• Strong understanding of laboratory workflows and the value of automation
• Confident, credible communicator with scientists and senior decision‑makers alike
• Self‑starting, commercially minded, and motivated by building something in a growth environment
• Willing and able to travel up to 50% across the region

 

Why This Role?

• A chance to play a key role in scaling US growth for a company with strong technology differentiation and momentum
• Significant autonomy and influence, with the opportunity to shape regional strategy and customer relationships
• High visibility internally and clear potential for progression as the business grows
• Collaborative, science‑driven culture that values initiative, curiosity, and long‑term partnerships

Are you an experienced QA and Regulatory professional ready to take on a pivotal leadership role within an exciting growing business? Our client is looking for a QA Regulatory Manager to oversee regulatory affairs for the UK business and assist with QA projects.

Reporting directly to the Head of Quality, this is a key strategic position interfacing with Quality Assurance, Regulatory Affairs, Operations and external regulators. You’ll play a critical role in shaping quality systems, ensuring inspection readiness, and supporting the development and supply of Investigational Medicinal Products (IMPs).

What you’ll do:

• Provide QA and regulatory leadership across all UK 6 facilities, ensuring consistent application of GMP, GDP and MHRA requirements.
• Act as the regulatory lead for IMP development activities, including review and approval of IMPDs, clinical trial quality documentation and supply processes.
• Lead interactions with MHRA and other regulatory bodies, supporting inspections, audits, responses and ongoing compliance commitments.
• Ensure site licences, variations and regulatory submissions remain current and aligned with operational activities.
• Harmonise and strengthen quality systems across multiple sites, covering deviations, CAPAs, change control, documentation and risk management.
• Provide QA project support for product development, technology transfer and validation activities within sterile production environments.
• Review and approve quality documentation, including SOPs, validation protocols, batch records and development reports.
• Serve as subject matter expert for aseptic GMP, IMP manufacture and regulatory expectations.

What you’ll bring:

• Proven Regulatory Affairs experience within sterile manufacturing or aseptic environments (5 years+)
• Proven QA management experience
• Hands‑on experience supporting IMP development, clinical trial supply and IMPD preparation/review.
• Strong working knowledge of UK/EU GMP, MHRA regulatory requirements and GxP compliance.
• Background in regulatory inspections, audits and authority interactions.
• Ability to work effectively with manufacturing, QC, development and clinical teams.
• Degree in a scientific discipline (or equivalent experience); further QA/regulatory qualifications are an advantage.
• Excellent communication skills, able to influence and collaborate at all levels.

Why Apply?

This is a rare opportunity to take on a high‑impact role within a specialised and mission‑driven aseptic pharmaceutical operation. You’ll shape the regulatory framework supporting both commercial products and innovative clinical development programmes—while working with a collaborative, highly skilled team committed to improving patient outcomes.

We are partnered with an agile, science-led pharmaceutical development consultancy, supporting clients across the full drug development lifecycle. Founded over a decade ago and grown from their ADME/PK roots, the business now delivers integrated development solutions from compound selection through to first-in-human and GMP clinical manufacturing.

We are now looking for an experienced Principal or Senior Principal Formulation Scientist to play a key technical role in a growing formulation team.

The Role

This is a senior, hands-on scientific position for someone who enjoys variety, ownership, and technical challenge.

You will:

• Lead and deliver multiple client-facing formulation projects (typically 3–5 personally)
• Provide technical formulation expertise across early-stage development through to GMP clinical manufacture
• Act as a trusted scientific advisor to clients, managing expectations and guiding decision-making
• Design and execute experimental development studies in the lab
• Mentor and coach junior scientists, providing guidance while allowing independence
• Contribute to project management and strategic direction, with scope to evolve into broader leadership over time

What We’re Looking For

Essential:

• PhD with 6+ years industry experience or MSc with 9+ years industry experience
• At least 3 years’ experience leading development projects
• Proven experience across the pharmaceutical development lifecycle, from early stage to GMP
• Strong hands-on formulation background
• Deep understanding of excipients and formulation material science
• Experience with tech transfer and first GMP batch manufacture
• Confidence interacting directly with clients and managing complex scientific discussions

Highly Desirable:

1. Experience with more complex modalities or delivery systems

Why Apply?

• Accelerated development: work on challenging, high-impact projects
• Breadth and autonomy: SME environment where scope is wide and progression isn’t limited by rigid structures
• Agile, expert-led culture: decisions are made by scientists, not layers of hierarchy
• Progression opportunity: Principal to Senior Principal and beyond, based on impact and capability
• Collaborative and approachable team: open-door culture, supportive and dynamic

If you’re passionate about pharmaceutical science, enjoy non-routine problem-solving, and want to make a tangible impact in a fast-paced consultancy environment, we’d love to hear from you.

 

Please note that this is an office-based role however up to 1–2 days remote possible per week on an informal-basis.

We are supporting a long-standing client with further expansion f their quality team across the UK.

This new position will take a business lead for all regulatory activities to support both clinical and commercial processes. You will work closely with several manufacturing facilities across the UK and will be the internal SME on all things regulatory.

Due to an increasing and evolving product portfolio, this new function will take a direct responsibility in liaising with the regulatory bodies and work with corporate QA. The split of the role will be around 70% regulatory focused but 30% of your time will still be attributed towards quality activities.

Whilst there are several sites, travel will be minimal. However, given the growing nature of the business, there is an expectation for this role to be site based initially with some flexibility moving forwards.

Key experience:

• Established regulatory experience (minimum 5 years) within pharmaceutical sterile/biological products
• IMP experience is essential
• Track record in leading communication with regulatory bodies
• Exceptional stakeholder management skills
• Ability to work in an evolving an fast paced business

For further information, please contact Mark Bux-Ryan.

I am delighted to be hiring for a brand new Site Manager position for a critical facility in a pharmaceutical manufacturing business that is experiencing rapid growth and demand.

Due to internal promotion, this position is an essential one in order to oversee all operations on a facility based in South Yorkshire. With responsibility for production, quality control and engineering, the demand on this position is high and will absolutely require the ability to be present, hands on and juggle priorities comfortably.

Whilst there are department managers as the direct reports, due to the size of the facility and ongoing need for continuous improvement, this position will need to be able to adopt a close working relationship with all employees in the facility.

This is a challenging, exciting opportunity that most definitely enables the opportunity for making an impact in a business that is moving in a very exciting direction, in a high demand market. 

Key experience:

• Leadership and management experience within a GMP pharmaceutical setting is essential
• Demonstrating experience and understanding across different operational disciplines is key
• Confident in operational challenges in a fast paced environment
• Strong experience in project management
• Technical understanding of sterile / aseptic manufacturing is essential

Please contact Mark Bux-Ryan for more information

We are partnering exclusively with a rapidly expanding advanced pharmaceutical organisation to appoint a senior leader responsible for Quality Assurance across multiple sites. Experience and eligibility as a Qualified Person (QP) is essential.

This position combines strategic oversight with hands-on leadership. While QP status is critical from an experience perspective, this role is not expected to perform as an operational QP.

It is critical to have managed or overseen QP teams and can demonstrate the capability to guide complex operational and compliance challenges. An understanding and capability of working in fast paced settings with the ability to make critical decisions is essential.
The role is fully remote and not tied to a single manufacturing site. However, regular on site engagement is essential, with an expectation to visit each UK facility on a regular basis. Flexibility to travel across the UK is therefore critical. A company vehicle or car allowance will be included as part of the overall benefits package.

Key Experience Required

• Robust and proven Quality Assurance background within the pharmaceutical sector
• Eligibility and previous experience as a QP
• Deep understanding and practical application of GMP
• Demonstrable people leadership capability and genuine passion for leading teams
• Hands-on experience within aseptic or sterile manufacturing environments
• Ability to lead teams effectively in a virtual setting; prior multi-site leadership is beneficial but not essential
• For further information, please contact Mark Bux-Ryan.