At a Glance
- Tasks: Ensure compliance with international regulatory requirements in biotechnology and healthcare.
- Company: Join a prestigious, innovation-driven biotechnology client.
- Benefits: Competitive salary, hybrid work, 25 days leave, and professional development support.
- Other info: Inclusive culture with great growth opportunities.
- Why this job: Make a real impact in the fast-paced world of biotech and healthcare.
- Qualifications: Strong understanding of EU and FDA regulations; excellent communication skills.
The predicted salary is between 40500 - 49500 £ per year.
Our prestigious client is seeking an experienced Regulatory Analyst to join a fast-paced, innovation-driven biotechnology client. This role focuses on ensuring compliance with international regulatory requirements for product development, clinical trials, and commercialization processes in the healthcare or life sciences sector.
The successful candidate will be responsible for compiling, reviewing, and submitting documentation to regulatory authorities and maintaining up-to-date knowledge of changing industry standards.
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 agencies.
- Monitor legislative and regulatory changes affecting product development and advise stakeholders.
- Collaborate with R&D, clinical, and legal teams to compile documentation for approvals.
- Maintain regulatory documentation databases and assist in audits or inspections.
- Support product labelling reviews and ensure proper documentation for promotional material approvals.
- Provide input on regulatory strategies during product lifecycle stages.
RequirementsRequired Skills:
- 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 Skills:
- Experience in biotechnology or pharmaceutical regulatory consulting.
- Familiarity with medical device regulations (MDR, IVDR).
- Knowledge of ICH guidelines, GxP, and ISO standards.
Job Benefits:
- Competitive base salary & performance bonus.
- Hybrid working flexibility.
- 25 days annual leave + bank holidays.
- Private medical insurance.
- Professional development and certification support.
- Inclusive, growth-oriented company culture.
Regulatory Analyst in London employer: MastarRec
Join a leading biotechnology firm that prioritises innovation and compliance in the healthcare sector. With a competitive salary, hybrid working options, and a commitment to professional development, this company fosters an inclusive culture that encourages employee growth and collaboration. As a Regulatory Analyst, you'll play a vital role in shaping product development while enjoying a supportive environment that values your expertise and contributions.
