Vacancy summary
Reference: 07622 Job Type: Contract Date Posted: 20 March 2019Vacancy summary
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Suzanne Bessant
Consultant
01753 830706
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
Want to know more?
Want to earn up to £500? *
*Terms and conditions apply
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