Regulatory Analyst
- Hiring from
- United Kingdom
- Work type
- Hybrid
- Posted
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About Us
MastarRec is a specialist recruitment and staffing agency supporting high-growth and technology-driven industries across the United Kingdom, the United States, and global markets. We partner with organizations to deliver tailored staffing solutions focused on quality, integrity, and long-term value for both clients and candidates.
Job Description
Description:
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.
Requirements
Required 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.
Benefits
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
