Life Sciences Regulatory Specialist

3 weeks 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.

  • Life Sciences Regulatory Specialist

    2 weeks ago

    Nottingham, Nottingham, United Kingdom Boots Full time

    SummaryJob Reference:BRNottingham Support OfficePermanent37.5 hours per weekClosing date: 24th April 2024About the roleThis 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...

  • Life Sciences Training Specialist

    1 month ago

    Nottingham, United Kingdom Generis Full time

    Company: Generis Enterprise Technology LimitedJob Title: Life Sciences Training Specialist (Remote)Location: Remote – UKContract Status: Full-time / Permanent Staff - 40 hours per week Mon-FriSalary: Dependent on experienceLife Sciences Training SpecialistJob Summary:The Life Sciences Training Specialist plays a crucial role in the development and delivery...

  • Regulatory Affairs Associate

    3 weeks ago

    Nottingham, United Kingdom Quotient Sciences Full time

    As Regulatory affairs associate this role will assist the Regulatory Lead in obtaining regulatory (MHRA), ethics and ARSAC approval for phase 1 clinical trials at Quotient Sciences, and for any phase 1/2 trials managed by Quotient Sciences. This role will be required to be on site 3 days per week minimum Main tasks and responsibilities - Prepare and collate...

  • Life Sciences Contracts Specialist

    4 weeks ago

    Nottingham, United Kingdom Boots Full time

    Summary Job Reference: - 229023BR Nottingham Support Office Permanent 37.5 hours per week **Closing date: 26 April 2024** About the role The Human Life Sciences sector is among the most valuable and strategically important in the UK economy, and critical to the country’s health, wealth, and resilience. Boots is the UK’s leading Health and Beauty...

  • Life Sciences Sales Specialist

    2 weeks ago

    Nottingham, United Kingdom Advanced Molecular Diagnostics Ltd Full time

    AMD is part of ADG group a leading provider of innovative solutions in the life sciences sector. Our commitment to advancing scientific research and development drives our dedication to supplying top-tier products and services to our clients. We are seeking a knowledgeable Life Sciences Sales Specialist to join our growing team. Job Summary: Key...

  • Life Sciences Sales Specialist

    2 weeks ago

    Nottingham, Nottingham, United Kingdom Advanced Molecular Diagnostics Ltd Full time

    AMD is part of ADG group a leading provider of innovative solutions in the life sciences sector. Our commitment to advancing scientific research and development drives our dedication to supplying top-tier products and services to our clients. We are seeking a knowledgeable Life Sciences Sales Specialist to join our growing team.Job Summary:Key...

  • Life Science Sales Specialist

    3 weeks ago

    Nottingham, United Kingdom Scientific Laboratory Supplies Full time

    Are you a passionate, high performing Scientific Sales Professional with Life Science experience? Do have the ability to communicate at all levels and want to be part of a growing team to make a real impact? Then Scientific Laboratory Supplies (SLS) is the right fit for you. Join us and contribute to our mission of being the UK's largest independent...

  • Life Science Sales Specialist

    4 weeks ago

    Nottingham, United Kingdom Scientific Laboratory Supplies Ltd Full time

    Are you a passionate, high performing Scientific Sales Professional with Life Science experience? Do have the ability to communicate at all levels and want to be part of a growing team to make a real impact? Then Scientific Laboratory Supplies (SLS) is the right fit for you. Join us and contribute to our mission of being the UK's largest independent supplier...

  • Quality and Technical Expert

    3 weeks ago

    Nottingham, United Kingdom VQ Life Sciences Full time

    **Quality and Technical Expert** **VQ Life Sciences **are recruiting for a **Permanent Quality and Technical Expert** based near Nottingham.** We have an opportunity for a **Quality and Technical Expert** to join a fantastic Quality team. If you have an interest in working in a fast paced, commercial Pharma Quality environment, or have relevant experience...

  • Life Sciences Co-ordinator

    3 weeks ago

    Nottingham, United Kingdom Boots Full time

    Summary Job Reference: 230858BR - Job Reference: 2 3 0 8 5 8 B R Nottingham Support Office Permanent 37.5 Hours **Life Sciences Co-ordinator** **Vacancy Closing date**:27th May **Recruitment Partner**: Laura Taylor As a Life Sciences Co-ordinator, you will focus on early and mid-stage business development in Life Sciences, encompassing work across...

  • Payroll Specialist

    2 weeks ago

    Nottingham, United Kingdom Quotient Sciences Full time

    Quotient Sciences is a drug development and manufacturing accelerator providing integrated programs and tailored services across the entire development pathway. Cutting through silos across a range of drug development capabilities, we help biotech and pharma customers save precious time and money in getting drugs to patients. As a growing and successful...

  • Quality Assurance Coordinator

    3 weeks ago

    Nottingham, United Kingdom Quotient Sciences Full time

    Quotient Sciences is a drug development and manufacturing accelerator providing integrated programs and tailored services across the entire development pathway. Cutting through silos across a range of drug development capabilities, we help biotech and pharma customers save precious time and money in getting drugs to patients. As a growing and successful...

  • Quality Assurance

    3 weeks ago

    Nottingham, United Kingdom Quotient Sciences Full time

    Quotient Sciences is a drug development and manufacturing accelerator providing integrated programs and tailored services across the entire development pathway. Cutting through silos across a range of drug development capabilities, we help biotech and pharma customers save precious time and money in getting drugs to patients. As a growing and successful...

  • Regulatory Affairs Specialist

    1 week ago

    Nottingham, United Kingdom GxPeople Global Full time

    GXPeople are looking for a RA Specialist to join a Medical Device SME client on full time & hybrid basis.The role will be part of a experienced QARA team. You will be responsible for writing technical file documentation and providing regulatory support in maintaining and updating Medical Device Technical files compliant with MDR/IVDR. In addition, you will...

  • Regulatory Affairs Specialist

    6 days ago

    Nottingham, United Kingdom GxPeople Global Full time

    GXPeople are looking for a RA Specialist to join a Medical Device SME client on full time & hybrid basis.Ready to apply Before you do, make sure to read all the details pertaining to this job in the description below.The role will be part of a experienced QARA team. You will be responsible for writing technical file documentation and providing regulatory...

  • Technical Specialist

    2 weeks ago

    Nottingham, United Kingdom Nottingham Trent University Full time

    **Diverse community. Inclusive Research. Rewarding Careers.**: **Doing things differently.**: **Technical Specialist - Sport Science**: £31,607 - 36,371 per annum Full-time, permanent **About the Role**: Interviews: week commencing 13th May 2024 **About Us**: The School of Science and Technology at Nottingham Trent University (NTU) is an exciting...

  • QA Associate

    3 weeks ago

    Nottingham, United Kingdom Quotient Sciences Full time

    **Company Overview** Quotient Sciences is a drug development and manufacturing accelerator providing integrated programs and tailored services across the entire development pathway. Cutting through silos across a range of drug development capabilities, we help biotech and pharma customers save precious time and money in getting drugs to patients. As a...

  • Formulation Scientist

    1 month ago

    Nottingham, United Kingdom Quotient Sciences Full time

    Quotient Sciences is a drug development and manufacturing accelerator providing integrated programs and tailored services across the entire development pathway. Cutting through silos across a range of drug development capabilities, we helpbiotech and pharma customers save precious time and money in getting drugs to patients. As a growing and successful...

  • Formulation Scientist

    2 weeks ago

    Nottingham, Nottingham, United Kingdom Quotient Sciences Full time

    Quotient Sciences is a drug development and manufacturing accelerator providing integrated programs and tailored services across the entire development pathway. Cutting through silos across a range of drug development capabilities, we helpbiotech and pharma customers save precious time and money in getting drugs to patients. As a growing and successful...

  • Gcp QA Associate

    3 weeks ago

    Nottingham, United Kingdom Quotient Sciences Full time

    **Company Overview** Quotient Sciences is a drug development and manufacturing accelerator providing integrated programs and tailored services across the entire development pathway. Cutting through silos across a range of drug development capabilities, we help biotech and pharma customers save precious time and money in getting drugs to patients. As a...