149 Regulatory Affairs Manager jobs in the United Kingdom

Regulatory Affairs Manager / Remote / 24.43 per hour PAYE

We are seeking an experienced Regulatory Affairs Manager to lead and support complex clinical trial application projects across Europe and beyond. This fully remote contractor role offers the opportunity to work on strategic regulatory initiatives, collaborate with global teams, and guide clients through the evolving EU Clinical Trials Regulation (EUCTR) landscape.

About the Role

This is a strategic, client-facing position focused on pre-approval clinical trial applications , particularly under the EUCTR framework. You will oversee regulatory submissions via the CTIS portal , manage cross-functional collaboration, and provide expert guidance on documentation, timelines, and regulatory strategy.

Key Responsibilities

• Lead EUCTR submissions, including preparation of core packages for Part 1 and coordination with local teams for Part 2 .
• Ensure familiarity with redactions and the regulatory distinctions between Part 1 and Part 2.
• Develop and execute regulatory submission strategies , including review of CMC and IMPD data.
• Provide strategic oversight of clinical trial applications, not limited to operational submission tasks.
• Collaborate with country teams on ethics submissions and post-submission maintenance (e.g., notifications, substantial amendments).
• Engage directly with clients to guide documentation requirements, set timelines, and communicate regulatory expectations.
• Review and manage project budgets, ensuring scope alignment and revenue recognition.
• Support global regulatory initiatives and contribute to SOP development and review.
• Mentor junior colleagues and contribute to internal training and development.

What We're Looking For

• Minimum 8 years of relevant regulatory experience in life sciences.
• Proven expertise in EUCTR , CTIS , and clinical trial applications .
• Strong technical writing skills, particularly in compiling IMPD and CMC data.
• Strategic mindset with experience in regulatory planning and client-facing communication.
• Ability to manage multiple projects, with assignments varying based on project size and scope.
• Experience in biotech, cell and gene therapy, or IVD is beneficial but not required.

Bonus Skills

• Experience with regulatory submissions in US, Canada, Latin America, or sub-Saharan Africa .
• Familiarity with regulatory portals such as Swissmedic and ARIS for UK submissions.
• Understanding of pharmacovigilance activities relevant to marketing authorisation transfers.

This is a 6 month Temporary contract with the potential to extend.

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JOB DESCRIPTION

Job Title    Regulatory Affairs Manager 

Salary    £40-55k, dependent upon experience 

Hours    Monday-Thursday 9:00-5:00; Friday 9:00-4.00 Office based, Full time Permanent Role, 37.5 hour per week

Summary    PROACT Medical Ltd is a fast-growing medical device company, specialising in airway management consumables and patient monitoring equipment. We are looking to employ a Regulatory Affairs Manager to oversee the application of the company’s Quality Management System, to ensure compliance with the applicable requirements of the essential requirements of the Medical Devices Directive 93/42/EEC and Medical Device Regulations (EU) 2017/745.

Reporting directly to the QA Manager (or in that person’s absence the Managing Director), the successful candidate will be responsible for implementing procedures to ensure the ongoing compliance of the company’s ranges of Class I medical devices, with particular focus on the aspects of Clinical Evaluation Files, Post-Market Surveillance and Risk Management.

The position will be based at our head office in Corby, Northants, working as part of the Regulatory Affairs and Quality Assurance Department, with close ties to the product management, warehouse and customer service teams.

Main Responsibilities

·   Managing a hands-on plan of action to audit and improve Technical Files, prioritising the Company’s own manufactured products.  This will also involve overseeing and training as necessary other members of staff to assist in these tasks.

·   Documentation and implementation of improved procedures relating to technical file management, with specific emphasis on:

• Clinical Evaluation Files
• Post Market Surveillance
• Risk Management
• Ensuring compliance of devices to all applicable regulations.

·   Drafting, maintenance and review of EC declarations of conformity for PROACT-manufactured devices.

·   Maintain registration of PROACT Devices on applicable online databases (EUDAMED, DORS, FURLS).

·   Monitoring the regulatory Landscape, notifying the Company of any relevant changes, and implementing changes as appropriate based on the scope of the Company’s activities.

·   Evaluating regulatory requirements for new markets and existing international distribution agreements (including FDA).

·   Work with the Company’s Directors and Managers and our IT team to develop and adjust our own internal software system (PROACT PORTAL) to allow the best and most efficient implementation of MDR and ISO13485:2016 requirements.

·   Deputising for the QA Manager in their absence, assisting as necessary with the administration of the QMS.

Qualifications & Experience

The following requirements should be supported by strong qualifications (preferably to degree level), or relevant working experience:

• Experience of working with Regulatory Affairs within the medical device industry is required, and knowledge of the current medical device regulatory frameworks EU MDR 745/2017, UK MDR SI 618/2002 & US FDA 21 CFR 820 is essential.
• Strong understanding of the requirements of ISO 13485:2016
• Experience drafting Clinical Evaluation Files in compliance with the guidance of MEDDEV 2.7/1

• Strong numeracy skills, with a focus on statistical analysis.
• Good computer skills – advanced understanding of Word, Excel and Outlook is essential. Knowledge of SQL query writing an advantage.
• Ability to liaise with colleagues, suppliers, customers and regulatory bodies professionally and diplomatically.
• Proven administrative and organisational skills.

Personal Qualities

• Ability to work on own initiative and in teams effectively.
• Keen attention to detail.
• Capacity to take on product knowledge and build relationships with suppliers, customers and colleagues.
• Willingness to adapt and respond to the varied requirements of a dynamic business.

Applications to be submitted with a current CV and covering letter / e-mail to:

Evita Misule, PROACT Medical, 9-13 Oakley Hay Lodge,

Great Folds Road, Corby, Northants, NN18 9AS

Job Title:

Job Title: Regulatory Affairs Manager

Location: London

Hours: Monday to Friday

Hybrid: 2 days home working per week

Role Summary

This position is focused on ensuring regulatory compliance across food and feed safety, product quality, and integrity standards. The role involves monitoring legislative developments, supporting compliance strategies, and collaborating with internal teams and exter
Make your application after reading the following skill and qualification requirements for this position.
Please click on the apply button to read the full job description

An opportunity has arisen in our Cambridge based Regulatory and Medical Affairs team for a Regulatory Affairs .

Job Title :

Job Title : Regulatory Affairs Manager

Location : London

Hours : Monday to Friday

Hybrid: 2 days home working per week

Role Summary

This position is focused on ensuring regulatory compliance across food and feed safety, product quality, and integrity standards. The role involves monitoring legislative developments, supporting compliance strategies, and collaborating with internal teams and exter.

Are you an experienced Regulatory Affairs Manager looking to make a impact in the chemical manufacturing industry? We are seeking a proactive and detail-oriented professional to lead the regulatory strategy and ensure full compliance across site operations.

As a Regulatory Affairs Manager , you will play a critical role in navigating complex regulatory environments, working cross-functionally with .

• Develop and implement regulatory strategies for product registration and lifecycle management.
• Prepare, review, and submit regulatory dossiers to health authorities (e.g., MHRA, EMA).
• Interpret and advise on regulatory requirements for new product development and clinical trials.
• Maintain regulatory compliance throughout the product lifecycle, including post-market surveillance.
• Liaise with health authorities, respond to queries, and manage regulatory inspections.
• Collaborate with R&D, quality assurance, and marketing teams to ensure regulatory alignment.
• Monitor changes in the regulatory landscape and assess their impact on the company's portfolio.
• Provide regulatory input for product labelling, advertising, and promotional materials.
• Manage regulatory affairs documentation and databases.
• Contribute to the development of regulatory policies and procedures.

• Bachelor's or Master's degree in Pharmacy, Life Sciences, Chemistry, or a related field.
• Significant experience in pharmaceutical regulatory affairs, with a strong understanding of global regulatory requirements.
• Proven experience in preparing and submitting regulatory dossiers (e.g., CTD).
• In-depth knowledge of relevant pharmaceutical regulations and guidelines.
• Excellent analytical, problem-solving, and communication skills.
• Ability to manage multiple projects and meet tight deadlines.
• Strong interpersonal skills and the ability to work effectively with cross-functional teams and external stakeholders.
• Experience in a hybrid work environment is beneficial.
• Experience with specific therapeutic areas is a plus.