Regulatory Analyst | Biotechnology | Healthcare Technology
Salary: £45,000 – £65,000 per year (Dependent on Experience)
Location: London, UK (Hybrid – 2–3 days in office)
Type: Permanent – Full Time
Industry: Biotechnology / Healthcare Technology
Job Owner: Tariq Masood
Job Description
Mastar Limited is seeking an experienced Regulatory Analyst to join a fast-paced, innovation-driven biotechnology organization.
This role is pivotal in ensuring regulatory compliance throughout the product development, clinical trials, and commercialization processes within the healthcare and life sciences sectors.
The successful candidate will be responsible for compiling, reviewing, and submitting documentation to regulatory authorities, while maintaining a thorough understanding of evolving international regulatory requirements and guidelines.
Experience
Minimum 3+ years in a regulatory or compliance role within biotechnology, life sciences, or healthcare industries.
Key Responsibilities
- Prepare, submit, and track regulatory filings such as INDs, NDAs, CTAs, and amendments.
- Ensure compliance with FDA, EMA, MHRA, and other global regulatory bodies.
- Monitor and interpret legislative and regulatory changes impacting product development.
- Collaborate with R&D, clinical, and legal teams to compile submission-ready documentation.
- Maintain organized regulatory documentation databases and assist during audits and inspections.
- Support labeling reviews, ensuring promotional materials meet compliance standards.
- Contribute to regulatory strategy discussions throughout the product lifecycle.
Required Skills
- Strong understanding of EU, UK, and FDA regulatory frameworks and submission processes.
- Experience with electronic submission platforms (e.g., eCTD).
- Excellent technical writing, documentation, and communication skills.
- Ability to handle multiple projects with attention to deadlines and compliance precision.
- High attention to detail and strong analytical thinking.
Desired Skills
- Experience in biotechnology or pharmaceutical regulatory consulting.
- Familiarity with medical device and IVD regulations (MDR, IVDR).
- Knowledge of ICH guidelines, GxP, and ISO standards.
- Understanding of clinical trial submissions and product lifecycle management.
Job Benefits
- Competitive base salary and performance-based bonus
- Hybrid working flexibility (2–3 days in office)
- 25 days annual leave + bank holidays
- Private medical insurance
- Professional development and certification support
- Inclusive and growth-oriented company culture
Education
- Bachelor’s degree in Life Sciences, Regulatory Affairs, Pharmacy, or related field.
- Advanced degree (Master’s or Postgraduate Diploma) preferred but not required.
Additional Details
- Experience Required: 3+ years in a regulatory or compliance function (life sciences/healthcare)
- Work Mode: Hybrid (London-based)
- Sponsorship: Not considered
