Regulatory Manager

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.

Role Purpose:

The QA Validation Manager will act as the critical interface between Quality Assurance and Operations, providing QA leadership, governance, and oversight of all validation activities across the business.

This newly created role establishes validation ownership within QA, ensuring validation activities are compliant, inspection‑ready, and aligned with regulatory, quality, and business expectations.

The role carries a strong sterile and aseptic manufacturing focus, supporting new product introductions, QC projects, and facility‑based projects across multiple UK sites.

Key Responsibilities:

QA Validation Leadership & Governance

• Act as the QA lead and approval authority for validation activities, ensuring compliance with GMP, Annex 1, MHRA, and internal quality standards.
• Establish and maintain QA oversight of validation strategy, including process, cleaning, equipment, utilities, computer systems, and facility validation.
• Review, approve, and assess risk related to validation master plans, protocols, reports, and deviations.

QA–Operations Interface

• Serve as the primary QA point of contact for Operations‑led validation activities, ensuring effective collaboration without duplication of effort.
• Challenge and support Ops validation activities from a quality and compliance perspective, acting as the independent QA voice.
• Support resolution of validation‑related deviations, CAPAs, and change controls.

Project Support (QC, NPI, Facility)

• Provide QA validation input into:
• QC projects
• New Product Introduction (NPI) projects
• Facility, equipment, and infrastructure projects
• Ensure validation requirements are built into project plans from initiation through execution and close‑out.
• Participate in cross‑functional project teams alongside QC, Engineering, Operations, and Regulatory.

Sterile / Aseptic Oversight

• Provide QA oversight for validation activities in sterile and aseptic manufacturing environments.
• Ensure Annex 1 expectations are appropriately interpreted and embedded into validation and qualification activities.
• Support inspection readiness and regulatory interactions related to sterile processing and validation.

People Management

• Provide line management, coaching, and development for 4 staff members.
• Set clear objectives, priorities, and performance expectations aligned with quality and project delivery goals.

Continuous Improvement & Systems

• Support the development and maintenance of validation and QA SOPs, templates, and standards.
• Contribute to inspection readiness, internal audits, and regulatory inspections.
• Identify opportunities to improve validation processes, documentation quality, and QA–Ops ways of working.

Skills & Experience Required:

Essential-

• Strong experience in GMP validation within a QA environment
• Background in sterile and aseptic manufacturing
• Experience reviewing and approving validation documentation from a QA perspective
• Practical experience with deviations, CAPAs, and change control related to validation
• People management or project leadership experience
• Willingness and flexibility to travel across multiple sites
• Confident communicator capable of influencing cross‑functional stakeholders

Desirable-

• Experience supporting QC, NPI, or facility‑based projects
• Previous involvement in regulatory inspections (MHRA or equivalent)
• Experience shaping or establishing QA validation frameworks or governance models

What This Role Offers:

• Opportunity to define and shape QA validation oversight in a growing, regulated environment
• High visibility role with direct access to the Head of Quality
• Exposure to varied projects across sterile operations, QC, facilities, and product development
• Clear people leadership responsibility and career progression potential

• Engineering qualification (Mechanical, Electrical, Chemical, or similar)
• Strong experience within a GMP pharmaceutical manufacturing environment (essential)
• Proven experience managing Capex projects alongside maintenance operations
• Hands‑on engineering capability with willingness to support troubleshooting and site work
• People leadership or people management experience
• Experience in sterile/aseptic environments (desirable)
• Knowledge of utilities such as HVAC, clean steam, compressed air, and purified water systems.
• Flexibility to participate in the site on‑call/weekend rota (overtime / TOIL available)