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Pharmaceutical Regulatory Affairs Specialist | £40k - £45k | Hertfordshire | Permanent

Are you a Regulatory Affairs professional with a sharp eye for compliance and a passion for guiding pharmaceutical products through every stage of their lifecycle?

Smart4 Sciences are working with a pharmaceutical manufacturing company that's looking for an experienced Regulatory Affairs Specialist to join their team. This is an exciting opportunity to play a vital role in ensuring the company's products meet UK and EU regulatory standards from early development through post-marketing.

Whether you're preparing submissions or staying ahead of evolving MHRA/EMA guidelines, this is a key position with real influence and variety.

The Role:

As Pharmaceutical Regulatory Affairs Specialist, you'll be responsible for:

Preparing and submitting regulatory dossiers (MAAs, variations, renewals) to health authorities.Leading post-marketing activities, including Type IA, IB, II variations, sunset clauses, re-classifications, and gap analyses.Reviewing and approving product labelling and packaging for compliance.Monitoring and interpreting regulatory changes from the MHRA, EMA, and ICH, and ensuring company-wide alignment.Acting as the key liaison with regulatory authorities, managing communications, responses, and inspections.Supporting cross-functional teams including Quality, Manufacturing, and Development with regulatory input.Contributing to regulatory strategy and lifecycle planning for pharmaceutical products.

What We're Looking For:

Degree in Pharmacy, Life Sciences, Regulatory Affairs, or a related discipline (advanced degree a bonus).Significant experience in Regulatory Affairs within the pharmaceutical industry.Solid understanding of EU/UK regulatory frameworks, including MHRA and EMA submissions.Strong knowledge of CMC (Chemistry, Manufacturing, and Controls) documentation and requirements.Familiarity with eCTD submissions and document management systems.A confident communicator who can represent the business to regulators and internal stakeholders alike.

Ready for your next move?

If you're a Regulatory Affairs specialist ready to join a fast-moving, supportive environment with a strong pipeline and clear compliance culture please apply today or contact Gareth Gooley at Smart4 Sciences on

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Join a leading logistics partner to the healthcare and pharmaceutical industry, as a Quality Manager & Responsible Person (RP). This is a crucial leadership role, responsible for site-level Quality operations, ensuring full compliance with GDP, MHRA, ISO, and internal quality systems.

Key Responsibilities

Lead and manage the on-site Quality department, overseeing personnel, operations, and performance.Act as the named Responsible Person for MHRA licences, ensuring adherence to GDP (2013/C 343/01).Ensure robust implementation of the Quality Management System including deviations, CAPAs, change control, and self-inspections.Maintain compliance with GxP, ISO 9001, ISO 13485, and regulatory standards.Conduct internal and external training on key QA topics and regulatory requirements.Oversee supplier management, quality risk assessments, validation processes, and complaint handling.Lead audit readiness and host MHRA, ISO, and client audits, ensuring timely resolution of any findings.Act as a key quality liaison for clients, attending meetings and maintaining strong working relationships.Prepare, review, and approve Technical and Quality Agreements.Ensure traceability of recalls and release of returned and quarantined stock in accordance with MHRA guidelines.

About You

Extensive experience in pharmaceutical or medical device quality assurance, preferably in a logistics/distribution setting.Eligible to act as Responsible Person (RP) under MHRA WDA(H) and WQP guidelines.Solid understanding of Good Distribution Practice (GDP) and the Falsified Medicines Directive.Working knowledge of environmental monitoring, computer systems validation, and ISO standards.Strong leadership, mentoring, and coaching skills - able to manage and motivate cross-functional teams.Excellent communication and stakeholder management capabilities.Proficient in Microsoft Office and quality systems; Lead Auditor certification is desirable.Willing to travel nationally and occasionally within Europe.

What's on Offer

Full benefits package including healthcare and pension.Opportunities to grow within a respected, international organisation.Collaborative and values-driven work culture.

Apply now to join a high-impact team where your expertise ensures the safe, compliant delivery of life-saving products or contact Gareth Gooley at Smart4 Sciences on

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Join a pharmaceutical leader dedicated to improving access to essential medicines and make your mark in regulatory excellence.
We are seeking a proactive and experienced Regulatory Affairs Manager to lead their Regulatory Affairs team and ensure full compliance with EU and GDP regulations. If you are a collaborative leader with a strong background in pharmaceutical distribution and regulatory affairs, this could be your next career-defining move.

Key Responsibilities

Lead, motivate, and supervise the regulatory approval team.Act as the main point of contact for team members and facilitate effective collaboration.Maintain and oversee accurate quality records, CAPAs, deviations, and SOPs.Coordinate with manufacturers and oversee recall operations when necessary.Conduct supplier and customer audits; lead self-inspections and follow-up actions.Ensure the appropriate handling and final disposition of returned, rejected, or falsified products.Oversee the relabelling and repackaging processes to comply with EU GDP standards.Ensure GDP training programs are implemented and continuously maintained.Maintain all documentation and licenses required for pharmaceutical distribution and regulatory compliance.Approve quality-related decisions, return-to-stock processes, and participate in distribution oversight.

What We're Looking For

Degree in Pharmacy or a related scientific discipline.Significant experience in Regulatory Affairs, ideally within pharmaceutical distribution/wholesale.In-depth knowledge of UK and EU pharmaceutical regulations (including GDP).Strong organisational and problem-solving skills, with attention to detail.Excellent communication and stakeholder management abilities.

What's on Offer

Competitive salary and performance-based incentives.Health insurance and comprehensive benefits package.Genuine opportunities for career development and growth.Flexible, collaborative, and inclusive work culture within a global company.

Ready to elevate your regulatory career?
Apply now and take your next step in a forward-thinking pharmaceutical environment or contact Gareth Gooley at Smart4Sciences on for more information.

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Senior QC Analyst

I am currently recruiting for a Senior QC Analyst for a Sterile Manufacturing organisation based in North Wales, this is an exciting opportunity for an established leader within QC to progress their career.

Key responsibilities for the Senior QC Analyst

Perform routine analytical testing via HPLC, GC, UV, FTIR, in compliance with cGMP regulations.Review analytical data and laboratory documentation.Provide technical guidance and support to junior analysts.Work with the Section Leader and QA team to Investigate OOS and OOT results, deviations, and support CAPAs.

Requirements for the Senior QC Analyst

Bachelor's degree in Chemistry or related subject.2-3 years of experience within Pharmaceutical QC.Good verbal communication skills.Experience within cGMP.

Benefits for the Senior QC Analyst

25 holidays per year + Bank HolidaysChristmas shutdown.Cycle to work schemeFlexible working hours.

To apply for the Senior QC Analyst or here more information, please contact Liam Shannon at Smart4Sciences on 01925 239723 or email me at

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QC Section Leader- Pharmaceuticals

I am currently recruiting for a QC Section Leader for a Sterile Manufacturing organisation based in North Wales, this is an exciting opportunity for an established leader within QC to progress their career.

Key responsibilities for the QC Section Leader- Pharmaceuticals

Lead and Supervise the QC Team ensuring deadlines are met within cGMP standards.Review any CAPAs, Change Controls and Deviations prior to QA approval.Write, review and develop internal SOPs for the most efficient process.Support method development, method validation and any equipment qualification.Lead batch release within the QC department.

Requirements for the QC Section Leader- Pharmaceuticals

Bachelor's degree in a Scientific discipline.Good understanding of GMP.5 years working within QC with Leadership.

Benefits for the QC Section Leader- Pharmaceuticals

25 holidays per year + Bank HolidaysChristmas shutdown.Early finish on a Friday and flexible working hours.

To apply for the QC Section Leader- Pharmaceuticals or here more information, please contact Liam Shannon at Smart4Sciences on 01925 239723 or email me at

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Regulatory Affairs Manager

I am working with a pharmaceutical/ Medical Device manufacturing site based in Deeside specialising in challenge meals, this is a good opportunity for a experienced Regulatory Affairs Manager to develop their career with an expanding company.

Key responsibilities for the Regulatory Affairs Manager

Develop and implement regulatory strategies for FDA and MHRA submissions.Lead the preparation, submission, and lifecycle management of regulatory dossiers.Work closely with the director with FDA and MHRA, coordinating meetings, and inspection readiness.Monitor changes in global regulatory landscapes and assess impact on ongoing and future projects.Provide regulatory guidance during product development, labelling, and promotional review processes.

Requirements for the Regulatory Affairs Manager

Bachelor's degree in a scientific discipline or a related subject.Minimum 5 years' experience in regulatory affairs, with demonstrable expertise in both FDA and MHRA regulatory processes.Strong knowledge of global regulatory standardsProven success in authoring and managing regulatory submissions and renewals.Excellent communication, leadership, and project management skills.

Benefits for the Regulatory Affairs Manager

25 holidays per year + Bank HolidaysChristmas shutdown.Cycle to work schemePrivate healthcareHigh street discount scheme

To apply for the Regulatory Affairs Manager or here more information, please contact Liam Shannon at Smart4Sciences on 01925 239723 or email me at

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Regulatory Affairs Officer - Pharmaceuticals & Medical Devices - Hull

Are you a Regulatory Affairs professional with a keen eye for compliance and a passion for bringing life-changing products to market? Smart4 Sciences partnering with a well-established pharmaceutical company who are looking to add a Regulatory Affairs Officer to their growing team.

About the Role:

As the Regulatory Affairs Officer, you'll play a critical part in ensuring regulatory compliance across UK, EU, and international markets. From product registration to post-market vigilance, you'll support the full lifecycle of innovative pharmaceutical and medical device products.

Key Responsibilities:

Compile and submit regulatory dossiers (new registrations, variations, renewals, CTAs).

Maintain current knowledge of MHRA, EMA, FDA, UK MDR 2002, and EU MDR 2017/745 requirements.

Liaise with regulatory bodies to resolve queries and secure timely approvals.

Manage post-market surveillance, change controls, and regulatory impact assessments.

Approve labelling and packaging for regulatory compliance.

Maintain regulatory databases and technical documentation.

What You'll Need:

Degree in a scientific discipline, chemical engineering or similar (or equivalent experience).

2+ years of regulatory affairs experience in pharma or medical devices.

Strong understanding of GMP, GDP, and ISO 13485.

Analytical mindset with excellent communication and problem-solving skills.

Experience influencing stakeholders and working cross-functionally.

Ready to take the next step in your regulatory career?
Apply now or contact Gareth Gooley on at Smart4 Sciences for a confidential conversation.

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QA Manager - Pharmaceutical Manufacturing
Northamptonshire | Competitive Salary + Benefits | Permanent, Full-Time

Are you an experienced QA professional ready to take the next step in your career? Smart4 Sciences are working with a leading pharmaceutical manufacturing company in Northamptonshire that's on the lookout for a skilled QA Manager to join their growing team.

This is a fantastic opportunity to take ownership of the Quality Assurance function on a busy GMP site, support a collaborative and quality-driven culture, and help shape the future of pharmaceutical manufacturing.

The Role:

As QA Manager, you'll lead a small but experienced QA team and take responsibility for the site's QMS, GMP compliance, and internal audit programme. You'll work closely with production, QC, and supply chain teams to ensure products meet regulatory standards and are released efficiently, working alongside the QP.

This is a hands-on leadership role in a company that values continuous improvement and employee development.

What You'll Be Doing:

Managing and mentoring the QA team

Leading GMP compliance across manufacturing and packaging operations

Owning and developing the Quality Management System

Hosting and supporting audits (MHRA, client, internal)

Overseeing deviations, CAPAs, change controls, and batch review

Working cross-functionally to drive quality improvements

What We're Looking For:

Solid QA background in pharmaceutical manufacturing

Proven experience managing or leading a QA team

Strong knowledge of EU GMP and GDP regulations

Comfortable leading audits and interfacing with regulatory bodies

A science degree (or equivalent experience) is preferred

Why Apply?

Be part of a forward-thinking and supportive company

Take ownership of quality strategy and improvements

Enjoy a stable, permanent position with real development prospects

Interested?
If you're a passionate QA professional looking for a new challenge in the Northamptonshire area, we'd love to hear from you.
Apply today or contact Gareth Gooley on for a confidential chat about the role!

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Technology Transfer Lead - Permanent - Humberside

** Lead Tech Transfer Projects for a Pharmaceutical expansion **

Are you a degree qualified chemical process engineer OR graduate in Pharmaceutical Sciences ?

Do you have expertise in ...

Pharmaceutical Formulation Development Process Development Scale up Technology Transfer

If you do & you would like the chance to join an expanding pharmaceutical organisation in the second phase of growth ...

Please apply now to Simon Fowler at NGAGE Smart4Sciences on 01925239725

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QA Manager / RP / RPi - Pharmaceuticals - Greater London Area

Are you an experienced Quality Assurance professional with RP and RPi eligibility, looking for your next challenge in a dynamic and expanding pharmaceutical company?

Our client, a rapidly growing and innovative pharmaceutical business based just outside London, is seeking a QA Manager who is also eligible to act as the Responsible Person (RP) and Responsible Person for Import (RPi) under GDP regulations. This is a hybrid role with excellent development prospects and the chance to make a significant impact in a highly collaborative team environment.

Key Responsibilities:

Oversee and continuously improve the company's Quality Management System (QMS)

Act as the Responsible Person (RP) and RPi, ensuring full compliance with GDP and MHRA expectations

Maintain and manage supplier and customer qualification processes

Lead audits (internal and external) and host regulatory inspections

Provide QA leadership across all GxP activities related to the import, storage, and distribution of medicinal products

Train, mentor, and develop QA staff

Support strategic projects including new product launches and licensing expansions

Requirements:

Eligibility to act as RP and RPi (MHRA named or ready to be named)

Strong background in pharmaceutical QA within a GDP/GMP environment

Excellent knowledge of EU GDP and UK regulatory expectations

Importation experience highly desirable

Personable, pragmatic, and proactive approach with great attention to detail

Prior experience working with a WDA(H) and MIA(IMP) license is a strong plus

What's On Offer:

A competitive salary and benfits package

Hybrid flexibility with a site located just outside London

Opportunity to grow with the business as it scales operations

🔍 Interested in learning more?
Apply now to take the next step in your QA career, or reach out confidentially to Gareth on for more information

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