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Life Sciences Regulatory Specialist

4 months ago

Nottingham, United Kingdom Boots Full time

Summary
Job Reference:

- 227332BR
Nottingham Support Office

Permanent

37.5 hours per week

**Closing date: 24th April 2024**

About the role

This is an exciting new role that is essential to support the set-up and delivery of Boots ambition in the Life Sciences sector, which is to deliver clinical research that improves health outcomes, whilst ensuring compliance with regulatory/industry standards. This is a full-time permanent position based in Nottingham or London.

As a Life Sciences Regulatory Specialist, you will focus on developing and delivering the compliance framework for clinical trials and other research, which adheres to relevant, up to date regulations and standards. Life Sciences at Boots includes a variety of services such as trial participant identification, recruitment and conduct of research.

The Life Sciences Regulatory Specialist is a member of the Healthcare Development and Public Affairs team, reporting into the Clinical Trials Manager.

**The Life Sciences Regulatory Specialist will be responsible for**:

- Managing and supporting with the set-up of the regulatory framework at Boots for clinical trials and other research to ensure compliance
- Reviewing and approving policies and regulatory guidance to ensure standards are maintained
- Maintaining an up-to-date knowledge of the Life Sciences regulatory landscape and external environment to inform others
- Acting as a point of escalation for regulatory issues which may need reporting internally or externally to contractual partners (i.e. a Sponsor) and regulatory bodies as appropriate
- Supporting with regulatory accreditation, inspections, or other internal and external audits
- Collaborating with the Clinical Trials team and the wider organisation to develop best practice guidance and governance procedures to support the safe delivery of clinical research
- Supporting with business development by building consistency and continuous improvement metrics into clinical research as Life Sciences at Boots evolves
- Identifying KPIs and implementing processes to monitor regulatory compliance
- Co-ordinating governance meetings with both internal stakeholders and external partners where required
- Using a validated Quality Management System

What you’ll need to have
- Knowledge of the legal and regulatory framework for Life Sciences, including clinical trials and other research
- Understanding and experience with Good Clinical Practice
- Experience communicating with regulatory authorities and an understanding of regulatory documents
- Experience of monitoring ongoing research to ensure adherence to regulation(s)
- Experience of managing non-compliance and deviations
- Clearly articulate technical/legal terms to different audiences using simple effective language
- Excellent stakeholder management skills
- Accurate and consistent with written documents
- Keep up to date with the external environment
- Continual improvement and learning mindset
- Ability to work at pace to meet deadlines as required

It would be great if you also have
- A relevant degree (i.e. in Science or Law) or Life Sciences industry experience
- Experience with regulatory submissions (i.e. MHRA)
- Internal and external auditing experience
- Knowledge of the legal and regulatory environment for medical devices used in clinical research

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

We have a great range of benefits in addition to the above that offer flexibility to suit you - find out more at boots.jobs/rewards. Please note, any salary estimates given on third-party sites are not provided or endorsed by Boots and may not be accurate.

Why Boots

At Boots, we foster a working environment where consideration and inclusivity help everyone to be themselves and reach their full potential. We are proud to be an equal opportunity employer, passionate about embracing the diversity of our colleagues and providing a positive and inclusive working environment for all. As the heart of everything we do at Boots, it's with you, we change for the better.

What's next

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