Senior Regulatory Affairs Specialist – Europe & UK

Serb; Weybridge; On-site; GBP 45,000 - GBP 65,000; Full time

Job summary

A leading specialty pharmaceutical company in the UK is seeking a Regulatory Affairs Specialist. This role involves managing regulatory compliance for licensed products, preparing submissions, and ensuring adherence to local regulations. Candidates should have a degree in a life science, prior Regulatory Affairs experience, and strong communication skills. The company values collaboration, ethical engagements, and offers competitive compensation, creating a supportive working culture.

Benefits

Competitive compensation

Comprehensive benefit packages

Supportive work culture

Qualifications

• Prior experience in Regulatory Affairs with MAA and life-cycle management.
• Ability to prepare, review, and maintain product information and CMC documentation.
• Experience in product development and new applications.

Responsibilities

• Manage preparation and submission to Regulatory Authorities.
• Evaluate post-marketing activities for compliance with regulatory licenses.
• Contribute to the maintenance of Company regulatory procedures.

Skills

Regulatory Affairs expertise

Life science education

Strong communication skills

Collaboration

Advanced computer skills

Education

Degree in a life science or Medical subject

Tools

Regulatory information management databases (e.g. Veeva RIM)

Microsoft Office

Job description

A leading specialty pharmaceutical company in the UK is seeking a Regulatory Affairs Specialist. This role involves managing regulatory compliance for licensed products, preparing submissions, and ensuring adherence to local regulations. Candidates should have a degree in a life science, prior Regulatory Affairs experience, and strong communication skills. The company values collaboration, ethical engagements, and offers competitive compensation, creating a supportive working culture.