Regulatory Affairs Manager

Boots; Greater London, Nottingham; On-site; GBP 40,000 - 60,000; Full time

Benefits offered by this job

Boots Retirement Savings Plan

Discretionary annual bonus

Enhanced parental leave

Job summary

Boots is seeking a Safety Advisor to join our Quality & Technical Services team. You will maintain vigilance processes across pharmacovigilance, medical device vigilance and cosmetovigilance, ensuring compliance with regulatory standards and internal policies.

Collaboration with customers, healthcare professionals and regulators will be key to successful post‑market surveillance. You will review safety data, prepare reports, and contribute to PSURs and trend analysis, while supporting audits,

Qualifications

• Experience reviewing safety data in a regulated environment.
• Strong attention to detail and regulatory compliance.
• Ability to manage multiple priorities and meet regulatory timelines.

Responsibilities

• Maintain pharmacovigilance, medical device vigilance, and cosmetovigilance processes.
• Liaise with customers, healthcare professionals, regulators, and internal stakeholders for post-market surveillance.
• Review, evaluate, and document safety reports and other product safety information.
• Analyze safety data to support case processing, trend analysis and escalation of concerns.
• Contribute to PSMF sections, procedures, signal management, literature reviews and PSURs.
• Manage cosmetovigilance activities and cosmetic product safety programs.

Skills

Product safety

Regulatory compliance

Post-market surveillance

Data review

Education

Science degree

Tools

Drug safety databases

Job description

Contract: Full-time, Permanent
Location: London or Nottingham

What you'll be doing

As a Safety Advisor at Boots, you’ll play an important role in maintaining and continually improving vigilance processes. This is a broad role and you will be part of a specialist team combining scientific assessment, regulatory compliance, post-market surveillance, safety signal management and stakeholder collaboration to ensure product safety activities are delivered in line with applicable regulatory requirements and company standards.

Key responsibilities

• Maintaining and continuously improve Boots' Pharmacovigilance, Medical Device Vigilance, and Cosmetovigilance processes.
• Liaise with customers, healthcare professionals, regulatory authorities, and internal stakeholders as part of the end to end post-market surveillance activities.
• Review, evaluate, and document Individual Case Safety Reports (ICSRs), medical device incidents and other product safety information.
• Perform analysis of safety data to support case processing, trend analysis and escalation of potential safety concerns
• Maintain allocated sections of PSMF, as well as authoring and maintaining procedures, signal management activities, including literature reviews and Periodic Safety Update Reports (PSURs), trend analysis and identification of emerging safety issues
• Perform Cosmetovigilance activities, including the management of undesirable effects and serious undesirable effects associated with cosmetic products.
• Monitor and assess relevant regulatory intelligence and changes in vigilance legislation to support ongoing compliance.
• Manage a Product Enquiry service, providing accurate and scientifically robust responses to customers.
• Support audits, inspections, and compliance activities as required.
• Deliver technical training on safety and vigilance processes across the business.
• Build effective relationships with internal and external technical stakeholders.

What you'll need to have (our must-haves)

• Experience in Product Safety, or a related scientific or regulatory discipline or a strong ambition to develop a career in these areas through relevant academic study
• Proven experience in reviewing and interpreting safety data within a regulated environment or the ability to critically evaluate complex information gained through academic study, research projects, or placements.
• Strong attention to detail and focus on quality and regulatory compliance.
• Strong organisational stills with the ability to manage multiple priorities and meet regulatory timelines.
• Good understanding of post-market surveillance principles and risk-based decision making.

It would be great if you also have

• Experience with drug safety databases or vigilance management systems.
• Knowledge of Good Pharmacovigilance Practice (GVP) and medical device vigilance requirements or a demonstrable interest in developing expertise in these areas.
• Previous experience in Cosmetovigilance activities and cosmetic product safety programmes.
• Knowledge of UK and/or EU cosmetic product legislation.
• Experience authoring or contributing to aggregate safety reports, signal detection activities, trend analysis or regulatory submissions.
• Understanding of risk management principles and benefit-risk assessment.

Where your brilliance can take you

At Boots, your role as a Safety Advisor opens doors to various career pathways within our Quality & Technical Services team. With opportunities for professional development and continuous learning, you can advance your expertise in product safety and regulatory compliance. Your contributions will not only enhance your career but also play a vital role in ensuring the safety and well-being of our customers.

Rewards designed for you

• Boots Retirement Savings Plan
• Discretionary annual bonus
• Enhanced maternity/paternity/adoption leave pay and gift card for anyone expecting or adopting a child
• Flexible benefits scheme including option to buy additional holiday, discounted gym membership, life assurance, activity passes and much more.
• Access to free, 24/7 counselling and support through TELUS Health, our Employee Assistance Programme.

There’s lots more in our benefits and discounts, MyBoosts – there to give you that little lift in your everyday. Find out more at http://boots.jobs/rewards. Exclusions may apply; eligible roles only. Please note that any salary estimates provided on third‑party sites are not endorsed by Boots and may not be accurate.

A bit about us

At Boots, we're proud to be an equal opportunity employer, creating a place where everyone feels welcome, supported and free to be themselves. We believe that when our people feel valued and included, they thrive, so we're committed to creating a brilliant Boots for our people so they can make a difference for our customers and colleagues every time.

What’s next?

If you apply, our team will be in touch to let you know the outcome of your application or to arrange next steps. Where a role is advertised as full-time, we are open to discussing part‑time and job share options. If you require additional support as part of the application and interview process, we are happy to provide reasonable adjustments to help you be at your best.

Boots is a Ban the Box employer and will consider the suitability of applicants with criminal convictions on a case‑by‑case basis.