Regulatory Analyst

MastarRec; Greater London; Hybrid; GBP 45,000 - 65,000; Full time

Job summary

A leading biotechnology firm is seeking an experienced Regulatory Analyst to ensure compliance with international regulatory requirements for product development. Responsibilities include preparing regulatory filings, monitoring changes affecting product development, and collaborating with cross-functional teams. The ideal candidate should have a strong understanding of EU and FDA regulations and excellent technical writing skills. This position offers competitive salary, performance bonus, and hybrid working flexibility.

Benefits

Competitive base salary & performance bonus

Hybrid working flexibility

25 days annual leave + bank holidays

Private medical insurance

Professional development support

Inclusive company culture

Qualifications

• Experience working with regulatory submission platforms.
• High level of attention to detail and compliance abilities.

Responsibilities

• Prepare and track regulatory filings such as INDs, NDAs, and CTAs.
• Ensure compliance with global regulatory agencies like FDA and EMA.
• Advise on legislative and regulatory changes affecting product development.

Skills

Strong understanding of EU and FDA regulatory frameworks

Excellent technical writing skills

Analytical thinking

Ability to manage multiple projects

Tools

eCTD regulatory submission platform

Job description

Job 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

• 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

• 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

Additional Financial Technology Requirements

Required Skills

• Deep knowledge of digital payment ecosystems, architectures, and technologies
• Expertise in payment gateway integration, tokenisation, and fraud detection systems
• Strong understanding of ISO 20022, EMV, NFC, and 3D Secure protocols
• Familiarity with cloud‑native architecture (AWS, GCP, or Azure)
• Ability to document and present technical concepts to stakeholders clearly

Desired Skills

• Experience with real‑time payment systems and blockchain‑based solutions
• Hands‑on coding experience with Java, Python, or Node.js
• TOGAF or AWS Solution Architect certification preferred
• Knowledge of financial data orchestration and embedded finance architectures