Job title: Senior Manager, Regulatory Affairs

A specialist, global pharmaceutical company in Berkshire are seeking a Senior Manager, Regulatory Affairs to lead and manage the Regulatory function. This opportunity will have overall responsibility for all regulatory activities across the EU and other markets.

Responsibilities:

• Development of regulatory strategies to ensure timely approval from various regulatory bodies
• Management of registration dossiers and submissions of MAA's across multiple territories
• Cross functional interaction with commercial, medical information, medical affairs and pharmacovigilance teams
• Leadership and training of employees within the regulatory affairs team
• Lead interactions with regulatory bodies such as the EMEA and MHRA
• Maintenance of labelling and product information to ensure compliance within guidelines

Requirements:

• Extensive experience within the Pharmaceutical industry, Medical Device experience is desirable
• Full product life cycle experience is essential - key focus on post approval
• Experience of working with Regulatory bodies such as the EMEA and MHRA. Middle East and Australia/New Zealand would be a bonus
• Previous experience of managing a product through the DCP/MRP/National approval process
• Previous line management experience is essential
• Life Science degree

Salary and benefits:

• Competitive annual salary
• Car allowance
• Performance related annual bonus
• Private medical insurance
• Income protection
• Life assurance

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