Regulatory Affairs Project Manager

My client is a leading global health care company We are a global, broad-based health care company devoted to discovering new medicines, new technologies and new ways to manage health.

They are looking for an experience individual to join growing team as the Regulatory Affairs Project Manager.

The main purpose of this role is to provide regulatory advice and support to the UK affiliate.

Main Responsibilities

• Gain marketing authorisations for new pharmaceutical products in the UK.
• Maintain marketing authorisations as required.
• Liaise with European Regulatory Affairs and corporate groups on regulatory issues.
• Liaise with external regulatory authorities as required.
• Draft of packaging texts, SmPCs, PILs and Prescribing Information.
• Liaise and attend meetings with other company functions to provide regulatory advice for new products.
• Maintain awareness of current and new legislation/guidance and ensure that work is in compliance with the statutory requirements.
• Manage regulatory projects and interact with other departments as necessary.
• To provide line management for any direct reports (if applicable) or mentor regulatory staff as required.
• To act as deputy Regulatory Affairs Manager as required.

Skills Needed

• High level of regulatory experience with a minimum of 2yrs UK experience
• Excellent communication skills, both verbal and written.
• The ability to thrive in a changing environment and to re-prioritise workload to meet business needs.
• Effective project management experience.
• Experience in people management would be desirable.
• Life Science Degree

If this sounds like the right opportunity for you then contact me so we can discuss this role in more detail.

Even if you are unsure on your suitability for this position but you are looking at the possibility of some progression in your current job or a change in your career path, please feel free to contact me for a friendly chat to explore any options that may be open to you. All enquiries will be dealt with in a strictly confidential manner. Call Matt on 01293 776644 or email me at mhart@barringtonjames.com