Regulatory Analyst

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