Senior Manager Regulatory Affairs

Job title: Senior Regulatory Affairs Manager

A Top 10 Pharmaceutical company in Berkshire are seeking a Senior Regulatory Affairs Manager to join their team. In this role you will implement regulatory strategies & deliverables for a portfolio of early/late development and marketed products in Europe.

Responsibilities:

• Implement regulatory strategies & deliverables including effective planning, tracking, archiving of activities, especially submissions for early/late development and marketed products in the assigned Therapeutic Area
• Responsible for ensuring planned drug development activities comply with Europe Region guidelines and in cases where they do not provides a critical analysis of the risks and issues.
• Supports the drug development strategy; defining options for Scientific Advice/Peadiatric Investigation Plan, creating briefing packages and co-ordinating and leading agency meetings.
• Responsible for direct liaison with EMA for products within the Therapeutic area.

Requirements:

• Pharmaceutical industry experience in Regulatory Affairs
• European regulatory experience is essential
• Experience of Immunology products is beneficial
• Experience working effectively across cultures and in complex matrixed environment.
• Excellent organizational skills and highly motivated.

Salary and benefits:

A highly competitive salary, car allowance, annual bonus, private healthcare and wider benefits are on offer

To apply for this position or hear further details then please click “Apply” or reach out via email – Freddie.hill@pharma-partners.co.uk