Regulatory Technical Advisor

Client:

I am working with an exciting midsize full service CRO with over 30 years of industry experience, with employees spread across 40+ countries. They have studies across all phases I-IV, and they cover a variety of therapeutic areas, including oncology, cardiology, endocrinology, central nervous system, metabolic diseases, and anti-viral. Having support them as a long term client, I am now excited to share a brand new regulatory technical advisor .

Responsibilities:

• Provide strategic advice on regulatory submissions, and give guidance to Regulatory Submissions Manager, project team and sponsors.
• Maintain and prepare Part I EU CTR submissions.
• Prepare and review key trial documents for compliance.
• Review regulations and guidance developing solutions to regulatory issues.
• Present during bid defenses and audits as required, and have independent interaction with sponsors and regulatory agencies.

Requirements:

• Minimum Bachelor's degree in life science area - Master's or PhD is preferred.
• Extensive experience in regional or global regulatory submissions.
• Strong understanding of regulatory documentation, guidelines and legislation.
• Experience in reviewing regulatory guidance and developing proactive solutions to regulatory issues.
• Strong communication, critical thinking and problem-solving skills.

Contact:

Nick Skouros, recruitment consultant

Phone number: +441293 77 66 44

Email: nskouros@barringtonjames.com