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Senior Regulatory Affairs Specialist

2 months ago

London, Greater London, United Kingdom Bionical Emas Full time
About the Role

We are seeking a highly skilled Senior Regulatory Affairs Associate to join our Early Access Programs (EAP) team on a fixed-term contract basis. This individual will work closely with 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.
  • Act as the client point of contact for regulatory activities for assigned Early Access Programs and attend regular client calls to provide regulatory updates, as required.
  • Provide initial assessments 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 the development and maintenance of the regulatory database of global regulations and guidelines.
  • Collaborate with the wider Bionical Emas Regulatory department to share learnings and provide Regulatory expertise as required.
  • Develop an 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 within the pharmaceutical or clinical research organization (CRO) environment.
  • Previous experience within EAP or compassionate use would be advantageous.
What We Offer
  • A dynamic and supportive work environment.
  • Opportunities for professional growth and development.
  • A competitive salary and benefits package.
  • A flexible and hybrid work arrangement.