Our client, a global pharmaceutical company with innovative and exciting growth plan, they are currently looking for a Regulatory Affairs Lead to be part of a highly effective European regulatory team.
As Strategy Lead for the UK & Ireland, you will be focused on developing post Brexit regulatory process for MHRA and driving regulatory activities for the UK as well as managing the Irish business's submission to the EMA. A great opportunity to build and develop this area, you will work on existing portfolio products as well as submissions and strategy for a new therapy area.
Key responsibilities
- Manage regulatory activities for the UK and Ireland on established and developing products
- Contribute to the creation of regulatory submissions and ensure all documents are submitted in a timely manner
- Liaise with and build good relationships with regulatory agencies and other internal and external stakeholders
Requirements
- Previous experience in a Regulatory Affairs Lead role particularly within a pharmaceutical or CRO industry
- Demonstrable experience in setting and implementing regulatory strategy at country level, as well as exposure to European wide strategy
- Oncology sector experience highly desirable
- Great understanding of regulatory submissions and post approval procedures as well as marketing authorisation in Europe and UK
- Exposure to Regulatory Affairs lifecycle management
- Excellent knowledge of UK and European Regulatory legislation and procedures essential as well as direct interaction with MHRA and EMA
- Ability to build rapport and build relationships is key to this role as well as communicating effectively at all business levels
- Proficiency in a European language is highly beneficial
Park Street People Ltd does not discriminate on the grounds of age, race, gender, disability, creed or sexual orientation and complies with all relevant UK legislation. We are acting as an Employment Agency in relation to this role.