Senior Regulatory Affairs Manager - Berkshire

Senior Regulatory Affairs Manager - Berkshire

Our client is an innovation led transnational pharmaceutical company producing a wide range of generic and branded formulations. The behaviour of their leadership team and people has created an environment where entrepreneurship and innovation thrive.

They are currently seeking a talented Senior Regulatory Affairs Manager to work from their Slough offices.

Reporting VP Scientific Affairs EMEA, you will take responsibility for and execute various regulatory activities in the EMEA and UK region.

These will include:

• Preparation, submission, and management of variation applications to agreed timelines
• Manage and submit Renewals and PSURs in line with specified timelines
• Preparation, submission, and management of approvals of National, Mutual Recognition and Decentralised Procedure applications in the region
• Preparation and maintenance of the product information
• Management of all regulatory activities related to the UK and EU markets
• Preparation of regular reports for regulatory and management purposes
• Support to the various business functions (e.g. portfolio, out licensing, launch management)
• Proactively contribute to the strategic development of the regulatory function as a whole and hence to the successful development of commercial operations in Europe, Middle East and Africa

Knowledge/Experience required:

• An in-depth understanding and experience of EU regulatory requirements
• Experience working in a UK affiliate is a requirement
• Experience in other non-EU markets in the region is an advantage
• Proven success in the timely management of regulatory approval procedures
• Ability to work to deadlines and able to successfully prioritise numerous projects simultaneously
• Ability to work independently as well as within a team
• Excellent verbal and written communication skill, IT skills at an advanced level
• Ability to work in a multicultural environment

This is a great place to enhance your career with a dynamic, talented and diverse workforce holding its corporate values and people agenda at the heart of its operations.

A Highly Competitive Basic, Bonus and Benefits package will be offered.

Please apply online or call CHASE to find out more on 0131 553 6644.

Reference number: 31564