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Senior Regulatory Affairs Specialist - 12 months FTC

map_markerUxbridge CoinNegotiable

Vacancy summary

Vacancy summary

Reference: 07622

Job Type: Contract

Date Posted: 20 March 2019

  • Working for a global pharmaceutical company
  • Excellent opportunity to work for a company that truly value their employees
  • Joining a fast paced, proactive team

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
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 Business in relation to this role.

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