Regulatory Affairs Senior Associate
CK Group are recruiting for a Regulatory Affairs Senior Associate to join a biopharmaceutical company at their site based in Uxbridge on a contract basis for 12 months.
- 24.52 PAYE or £32.22 Umbrella
Regulatory Affairs Senior Associate Role:
- Assist Regional Regulatory Lead to support regional regulatory filing activities (e.g. CTA package development and submission)
- Provide and maintain CTA/MA documentation (e.g. variations, substantial amendments, PDCO annual reports) in collaboration with Regional Regulatory Lead
- Coordinate collection of functional documents in support of regulatory applications
- Prepare regulatory packages and cross-reference letters to support investigator sponsored studies
- Actively support regulatory compliance, and ensure compliance via timely submissions to regulatory agencies
- Relevant experience in Regulatory Affairs, especially regarding Clinical Trial Applications (CTAs) in the EU region.
- Understanding of drug development process
- Strong communication skills - oral and written
- Organizational skills
Our client is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics.
This Regulatory Affairs Senior Associate role will be based at our clients site in Uxbridge, Greater London. Remote working is available but the client would prefer the successful candidate to be based on site.
Entitlement to work in the UK is essential. For more information, please contact Lucy Stendall on 01438 870011 or email firstname.lastname@example.org. Please quote reference 50888.