Senior Regulatory Affairs Specialist

2 days ago


Newcastle upon Tyne, Newcastle upon Tyne, United Kingdom Bionical Emas Full time
About the Role

Bionical Emas is seeking a highly skilled Senior Regulatory Affairs Associate to join our EAP team on a fixed-term contract basis. This individual will work to deliver strategic and operational regulatory support and expertise to the Regulatory team and clients to ensure efficient and compliant set-up, maintenance, and close-out of projects.

Key Responsibilities
  • Manage day-to-day regulatory affairs activities to ensure compliance with regulatory obligations and requests
  • Provide an initial assessment for feasibility reviews or regulatory questions as required, with support from a senior regulatory team member
  • Develop Regulatory Strategy Reports and/or regulatory plans at the start of each project
  • Manage and maintain trackers of regulatory activities relating to set-up, maintenance, and close-out of projects
  • Develop key regulatory documents for regulatory submissions, including performing regulatory review of protocols and Informed Consent Forms
  • Prepare, collate, and submit packages for regulatory submissions in line with local requirements, with support from a senior regulatory team member
  • Support with the development and maintenance of the regulatory database of global regulations and guidelines
  • Work closely with wider Bionical Emas Regulatory department to share learnings and to provide Regulatory expertise as required
  • Develop own external regulatory network relating to Regulatory Affairs for the purpose of regulatory intelligence and continuous professional development
  • Perform and manage administration of regulatory release of shipments
Requirements
  • Bachelor's degree in a healthcare/science-related subject preferred
  • Previous experience in regulatory affairs field within the pharmaceutical or clinical research organization (CRO) environment
  • Previous experience within EAP or compassionate use would be advantageous


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