Senior Regulatory Affairs Specialist - 12 months FTC

Senior Regulatory Affairs Specialist - 12 months FTC

A Global Pharmaceutical company based in Uxbridge is currently looking to recruit a Senior Regulatory Affairs Specialist - 12 months to join their team. We are seeking a talented individual who is ready to hit the ground running on a 12-month contract and would thrive in joining this fast-paced department. Your main focus will be to support regulatory activities for Clinical Trial Authorisation (CTA) applications including dossiers and approvals. 

Responsibilities include:

• Reviewing the submission strategies for the projects by contributing to the development and preparation of high-quality regulatory CTA dossiers and other dossier (licence variation applications, PIP modifications, DSUR applications, IB updates), ensuring compliance with regulatory requirements
• Working and supporting the existing studies (amendments, DSUR applications, IB updates, TMF reviews)
• Reviewing and checking and documents necessary for submissions
• Assisting with developing the strategy and plans within the regulatory
• Making sure the Content Plan is delivered on time
• Responsible for tracking all the activities, delivering projects on time and submissions
• Making sure the company has got archived copies of the regulatory documents
• Managing any updates in terms of regulatory guidance and procedures and making sure everyone is aware

Skills and knowledge:

• A scientific degree (Batchelors or equivalent and above)
• Previous experience in Regulatory Affairs and Compliance within pharmaceutical industry
• Strong experience in CTA applications is required
• Ability to multitask and prioritise work flow
• Excellent communication and time management skills
• Strong attention to detail
• Ability to work within the team with leadership attitude