Job title: Regulatory Affairs Manager

A growing Biopharmaceutical business in Oxfordshire, are looking to expand their Regulatory Affairs team. This role will focus on lifecycle activities for a marketed product within Oncology. Future pipeline will lead to pre-approval and clinical development activities.

Responsibilities:

• Support the preparation, review, and submission of post-approval global regulatory submissions as appropriate, (e.g. variations, meeting requests, briefing packages, annual reports, periodic safety reports).
• Provide in-depth reviews of protocols, reports, presentations, and documents
• Participate in the electronic review and quality verification of regulatory submissions
• Review and interpret recent product approvals, current regulatory guidance documents, and recent public Advisory Committee proceedings to support development of regulatory strategies

Requirements:

• Bachelors or Masters or advanced degree in a scientific discipline
• 5 years of experience in the pharmaceutical and/or biologics industries
• Demonstrated understanding and strategic application of regulations and guidelines for drug development

Salary and benefits:

A competitive salary, car allowance, bonus, pension, healthcare and stock options are on offer

To apply for this position or hear further details then please contact Matt Thomas via matt.thomas@pharma-partners.co.uk