Regulatory Affairs Specialist | Clinical Trials, FDA, EMA Compliance
Salary: £45,000 – £65,000 per year (DOE)
Location: London, UK or Hybrid (2 days per week onsite)
Type: Full-Time
Industry: Biotechnology / Healthcare Technology / Pharmaceuticals
Job Owner: Tariq Masood
Job Description
We are seeking a highly skilled and detail-oriented Regulatory Affairs Specialist to join a leading life sciences and medical technology organization.
In this pivotal role, you will support the development, submission, and maintenance of regulatory documentation for clinical trials, product registration, and post-market surveillance activities, ensuring compliance with FDA, EMA, MHRA, and other global regulatory bodies.
This position offers an exciting opportunity to contribute to regulatory strategy, gain cross-functional exposure, and work on cutting-edge biotech and medical device products within a dynamic, fast-paced regulatory environment.
Experience
2–5+ years of experience in regulatory affairs within the pharmaceutical, biotechnology, or medical device industries.
Key Responsibilities
- Prepare, compile, and submit regulatory documentation (INDs, CTAs, 510(k), CE marking, etc.).
- Ensure compliance with FDA, EMA, MHRA, ISO, and ICH guidelines.
- Collaborate with R&D, Clinical Affairs, and Quality Assurance teams to ensure product readiness.
- Maintain regulatory files, technical documentation, and product registrations across global markets.
- Monitor regulatory changes and provide internal guidance on updates and implications.
- Support internal and external audits and regulatory inspections.
- Assist in labeling review, risk assessments, and post-market surveillance activities.
Required Skills
- Strong understanding of global regulatory requirements (FDA, EMA, MHRA, ISO 13485).
- Excellent written and verbal communication skills.
- Experience in regulatory dossier preparation and submission management.
- High attention to detail with strong documentation and project tracking abilities.
- Proficiency with Microsoft Office and regulatory software systems.
Desired Skills
- Regulatory Affairs Certification (RAC) or equivalent credential (preferred).
- Experience handling medical device, diagnostic, or biotech regulatory submissions.
- Knowledge of eCTD publishing tools and Regulatory Information Management Systems (RIMS).
- Ability to interpret technical documentation and scientific data effectively.
Job Benefits
- Competitive base salary with performance-based bonuses
- Private health and dental insurance
- Annual training and certification reimbursement
- 25 days holiday + bank holidays
- Hybrid working model with flexible scheduling
- Excellent career growth opportunities within an expanding regulatory team
Education
- Bachelor’s degree in Life Sciences, Pharmacy, or Regulatory Affairs (Master’s preferred).
Additional Details
- Experience Required: 2–5 years minimum in regulatory affairs (biotech, medtech, or pharma preferred)
- Work Mode: Hybrid (2 days onsite per week)
- Sponsorship: Not considered
