Global Regulatory Analyst – Biotech Submissions & Compliance

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

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.