Regulatory Affairs Manager UK & Ireland - part time (3 days per

We are currently working with a Specialist Pharma company with a global presence.

Role:

This is a role involves heading up Regulatory Affairs activities for the UK / Ireland Affiliate for 3 days a week. The role acts as a local safety representative for Pharmacovigilance purposes.

Location:

The position is based in their London office with the flexibility for 1 day of home working if desired  

Responsibilities:

Regulatory:

·        Ensure regulatory submission (National applications) is completed in a timely manner & ensure the companies interests are aligned to and represented by the Global Regulatory Affairs teams. 

·        Perform routine regulatory activities i.e. maintenance/renewals, variations, 61(3) notifications.

·        Provide technical input where required

·        Ensure artworks are created and approved in time for product launches

·        Maintain current knowledge of regulatory affairs legislation

·        Ensure all regulatory databases are kept up to date

·        Provide support for marketing material

·        Monitor and interpret local regulatory issues and trends that will impact the marketability of company products and ensure that the company is aware of significant regulatory issues

Safety contact (Pharmacovigilance), experience preferred not essential:

·        Ensure pharmacovigilance activities performed are completed in a timely manner, and in accordance with pharmacovigilance legislation, acting as deputy (back‐up) to compliance manager.

·        Ensure PSUR's are submitted in accordance with agreed schedules.

·        Maintain effective dialogue with pharmacovigilance contract providers acting as deputy (back‐ up) to compliance manager.

·        Ensure regulatory changes to product information are provided in a timely manner to the pharmacovigilance contract provider and all relevant departments acting as deputy (back‐up) to compliance manager.

Quality Assurance, experience preferred not essential:

·        Prepare and maintain Product Compliance Files

·        Review of validation documents

·        Ensure Quality systems are maintained

·        Ensure retained samples are stored in accordance with SOP

·        Prepare/review SOP's where required

For further information please get in touch with Natalie Jones on 0207 183 5059 / natalie@linkfieldgroup.com