Senior Regulatory Affairs Specialist
2 days ago
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
- 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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