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1,574
Clinical Trial jobs in United Kingdom
Project Manager, Regulatory Affairs
AbbVie
Taplow
On-site
GBP 50,000 - 70,000
2 days ago
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Remote Implementation Consultant, Patient Cloud
Dassault Systèmes
City of Westminster
Remote
GBP 50,000 - 70,000
2 days ago
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Europe Regulatory Affairs Project Lead
AbbVie
Taplow
On-site
GBP 50,000 - 70,000
2 days ago
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Senior In-House CRA II — Oncology Trials (Remote)
Precision For Medicine
City of Westminster
Hybrid
GBP 40,000 - 55,000
2 days ago
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Global Regulatory Disclosures Lead
Roche
England
On-site
GBP 60,000 - 80,000
2 days ago
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Discover more opportunities than anywhere else. Find more jobs nowSenior Specialist, CSO Labelling
Bristol-Myers Squibb Company
England
Hybrid
GBP 45,000 - 60,000
2 days ago
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Senior CSO Labelling Specialist — Global Clinical Trials
Bristol-Myers Squibb Company
England
Hybrid
GBP 45,000 - 60,000
2 days ago
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Connect with headhunters to apply for similar jobsClinical Research Fellow
Moorfields Eye Hospital NHS Foundation Trust
City of Westminster
On-site
GBP 80,000 - 100,000
2 days ago
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Senior Clinical Research Practitioner
Cardiff and Vale University Health Board
Wales
On-site
GBP 35,000 - 45,000
3 days ago
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Research Sister/Charge Nurse
University Hospitals Coventry and Warwickshire
Coventry
On-site
GBP 30,000 - 40,000
4 days ago
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Parkinson's Disease Research Sister / Charge Nurse
University Hospitals Coventry and Warwickshire NHS Trust
Coventry
On-site
GBP 38,000 - 47,000
7 days ago
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Single Sponsor Senior CRA - Oncology (UK based) Must have UK on-site and risk based monitoring exp)
Syneos Health, Inc.
Greater London
On-site
GBP 45,000 - 60,000
3 days ago
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Research Portfolio Manager
The Christie NHS FT
Manchester
On-site
GBP 38,000 - 47,000
6 days ago
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Clinical Research Practitioner
University Hospitals Sussex NHS Foundation Trust (279)
Brighton
On-site
GBP 25,000 - 35,000
3 days ago
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Clinical Research Practitioner
University Hospitals Sussex NHS Foundation Trust
Kemp Town Estate
On-site
GBP 30,000 - 40,000
4 days ago
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Tissue Manager
The Royal Marsden NHS Foundation Trust
Greater London
On-site
GBP 35,000 - 50,000
3 days ago
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Clinical Research Nurse / Practitioner
Norfolk and Norwich University Hospitals NHS Foundation Trust
Norwich
On-site
GBP 30,000 - 40,000
3 days ago
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Research Nurse
Somerset NHS Foundation Trust
Yeovil
On-site
GBP 30,000 - 40,000
3 days ago
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Senior Research Practitioner (Outside 2 Study)
Sussex Partnership NHS Foundation Trust
Rottingdean
Hybrid
GBP 60,000 - 80,000
3 days ago
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Clinical Research Associate - UK
Thales Group
Cheadle
On-site
GBP 35,000 - 45,000
3 days ago
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Research Operations Manager | Oxford University Hospitals NHS Foundation Trust
Oxford University Hospitals NHS Foundation Trust
Oxford
On-site
GBP 45,000 - 60,000
3 days ago
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Project Manager, Regulatory Affairs
AbbVie
Taplow
On-site
GBP 50,000 - 70,000
Full time
3 days ago
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Job summary
A leading global biopharmaceutical company in the UK is seeking a Regulatory Affairs professional to implement regulatory strategies and manage product compliance. The role involves interfacing with commercial teams and health authorities, as well as supporting the drug development strategy. The ideal candidate should have a strong understanding of regulatory requirements in Europe, proven experience in lifecycle management, and the ability to lead regulatory submissions effectively.
Qualifications
- Experience in regulatory strategies for pharmaceutical products.
- Strong understanding of EU and non-EU regulatory environments.
- Ability to manage product lifecycle and compliance.
Responsibilities
- Implement regulatory strategies for a portfolio of products.
- Manage submissions and lifecycle for compliance.
- Interface with brand teams and local health authorities.
Skills
Regulatory compliance
Knowledge of regulatory procedures
Leadership skills
Strategic planning
Communication skills
Job description
- Implement regulatory strategies & deliverables for a portfolio of products early/late development or marketed products for the Europe Area Regulatory Affairs (ERA) including EU and non-EU countries such as CEE countries, Israel, Turkey, Switzerland and the UK. Include fair representation of the interest of EU countries into Global Regulatory Product Teams in alignment with the overarching global regulatory strategy and region specific requirements.
- Responsible for assigned product maintenance and lifecycle management submissions, in line with legal/regulatory requirements and regional business needs.
- Contribute, as required, in the development of regional processes to maximize operational efficiency of regulatory activities within the region.
- Develops and maintains knowledge of regulatory procedures and environment within the region.
- Primary RA interface with Commercial Area Brand Team and in collaboration with the RA personnel in the affiliates., Implement regulatory strategies & deliverables including effective planning, tracking, archiving of activities, especially submissions for early/late development and marketed products
- Supports co-ordination of the review of CMC, QRD, PSUR and labelling submissions and approval of product-related packaging as required to ensure regulatory compliance.
- Supporting the drug development strategy, defining options for including supporting Scientific Advice/PIP/IMPD, creating briefing packages and co-ordinating and leading agency meetings logistics
- Primary RA interface with Commercial Area Brand Team. Represent RA on Area Brand Teams
- Provide strategic input for registration, ensure the business needs are met by anticipating and mitigating regulatory risks
- Primary interface to and from the RA personnel in the affiliates and provides product updates in Area Regulatory Product Teams (ARPTs)
- Primary interface with local health authorities (via RA personnel in the affiliates where appropriate)
- Interface with EMA for products within the Therapeutic Area on behalf of the Product Lead when required.
- Provide leadership and support to RA personnel in the affiliates through ongoing communication. Assess scientific data provided by specialist units for registration purposes against ERA regulatory requirements, identifying gaps and developing mitigation strategies. Ensure effective presentation of data, complete and timely responses (including CTAs)
- Provide Europe Area input on local implications through participation in Teams as needed (e.g. submission teams, labelling working group including development of labelling negotiations).
- Ensure regulatory compliance within ERA for the assigned compounds/products. Implement remediation plan to address identified gaps, if any.
- Support development and implementation of new processes and ensure that these meet regional regulations and needs
- Responsible for the Notification of Regulatory activities and related database entry/data accuracy for allocated projects.
* The salary benchmark is based on the target salaries of market leaders in their relevant sectors. It is intended to serve as a guide to help Premium Members assess open positions and to help in salary negotiations. The salary benchmark is not provided directly by the company, which could be significantly higher or lower.