Life Sciences Regulatory Affairs Associate
| Company: | BIOPATH LTD |
|---|---|
| Salary: | £49,000 to £55,000 a year |
| Hours: | Full-time |
| Location: | London, SE1 2RE |
| Working pattern: | On-site |
| Job type: | Permanent |
| Posting date: | 29 Sept 2026 |
| Closing date: | 29 Oct 2026 |
Summary
Biopath Ltd is seeking a Life Sciences Regulatory Affairs Associate to support the development and delivery of its regulatory compliance and quality-assurance services across the life-sciences sector.
The successful candidate will manage assigned regulatory workstreams, interpret relevant UK and international regulatory requirements, assess scientific and technical documentation, and help ensure that company and client activities meet applicable quality standards, professional codes and internal procedures.
The position includes regulatory research, compliance planning, controlled-document management, quality review, regulatory risk assessment and the preparation of audit-ready records. The Associate will work closely with senior management, scientific specialists, clients and external stakeholders across biotechnology, pharmaceuticals, healthcare, diagnostics and related life-sciences activities.
KEY RESPONSIBILITIES
- Research, interpret and monitor relevant UK and international legislation, regulatory guidance, industry standards and professional codes.
- Manage assigned regulatory compliance and quality-assurance workstreams.
- Develop and maintain regulatory compliance plans, trackers and reporting schedules.
- Review scientific, medical, technical and educational materials for regulatory accuracy, consistency and compliance.
- Conduct regulatory gap assessments and identify compliance risks, corrective actions and areas requiring further evidence.
- Prepare regulatory reports, evidence summaries, compliance assessments and recommendations for management and clients.
- Coordinate the preparation, review, approval, version control and retention of controlled documents.
- Maintain standard operating procedures, quality records and audit-ready documentation.
- Support document change control, deviation investigations, corrective and preventive actions and internal quality reviews where applicable.
- Monitor regulatory developments and assess their potential impact on company services and client projects.
- Support the preparation and maintenance of regulatory submissions, registrations and supporting documentation where required.
- Advise internal teams and clients on regulatory requirements, documentation standards and quality procedures.
- Coordinate with scientific, medical and commercial stakeholders to ensure that regulatory requirements are incorporated into project delivery.
- Contribute to the development of Biopath’s regulatory compliance and quality-assurance services across the wider life-sciences sector.
- Represent the company professionally at client meetings, regulatory discussions and relevant industry events.
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