Regulatory Analyst
$45,000–$65,000 year
HybridLondon, England, United Kingdom
Job Summary
Prepare, submit, and track regulatory filings including INDs, NDAs, CTAs, and amendments while ensuring compliance with FDA, EMA, MHRA, and other global agencies. Monitor legislative changes affecting product development and advise stakeholders, then collaborate with R&D, clinical, and legal teams to compile documentation for approvals. Maintain regulatory documentation databases, assist in audits or inspections, and support product labelling reviews for promotional material approvals. Provide input on regulatory strategies during product lifecycle stages. This role ensures compliance with international regulatory requirements for product development, clinical trials, and commercialization within a prestigious biotechnology client.
Required Qualifications
- Strong understanding of EU and FDA regulatory frameworks and submission processes
- Experience working with regulatory submission platforms (e.g., eCTD)
- Excellent technical writing, documentation, and communication skills
- Ability to manage multiple projects with attention to deadlines and compliance
- High level of attention to detail and analytical thinking
Desired Qualifications
- Experience in biotechnology or pharmaceutical regulatory consulting
- Familiarity with medical device regulations (MDR, IVDR)
- Knowledge of ICH guidelines, GxP, and ISO standards
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