Regulatory Affairs Specialist
7 days ago
We are seeking a highly skilled Senior Regulatory Affairs Associate to join our EAP team on a fixed-term contract basis. This individual will provide 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.
- 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.
- Work closely 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.
- 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.
- 25 days of vacation.
- Vacation days purchasing scheme.
- 1 extra vacation day per each 3 years of service.
- Discretionary Annual Bonus.
- Sabbatical of 3 to 6 months (after 2 years of service).
- Free food and beverages at all offices.
- Life Insurance.
- Health Insurance and Employee Assistance Programme.
- Employee Support Networks – help us continue to build on our inclusive culture.
- Flexible and hybrid work.
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Glasgow, Glasgow City, United Kingdom Lawes Consulting Group Full timeQuality Assurance and Regulatory Affairs OfficerOverviewWe are seeking a detail-oriented and organized Quality Assurance professional to join our client's team as a QA Audit/Compliance Analyst. The ideal candidate will be responsible for ensuring that the organization adheres to regulatory standards and company policies, while maintaining the highest level...
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Glasgow, Glasgow City, United Kingdom Lawes Consulting Group Full timeQuality Assurance and Regulatory Affairs OfficerOverviewWe are seeking a detail-oriented and organized Quality Assurance professional to join our client's team as a QA Audit/Compliance Analyst. The ideal candidate will be responsible for ensuring that the organization adheres to regulatory standards and company policies, while maintaining the highest level...
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Public Affairs Specialist
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Public Affairs Specialist
7 days ago
Glasgow, Glasgow City, United Kingdom Stepchange Full time### Job OverviewAt StepChange Debt Charity, we're seeking a skilled Public Affairs Specialist to join our team.### Key Responsibilities* Provide strategic advice on public affairs and policy issues* Develop and implement effective communication plans* Build and maintain relationships with key stakeholders### What You'll Need* Proven experience in public...
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Public Affairs Specialist
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Public Affairs Specialist
6 days ago
Glasgow, Glasgow City, United Kingdom StepChange Debt Charity Full timeJob OverviewWe are seeking a skilled Public Affairs Officer to join our team at StepChange Debt Charity.About the RoleAs a Public Affairs Officer, you will play a critical role in influencing policy and advocating for those in need.Key ResponsibilitiesDevelop and implement effective communication strategies to engage stakeholders and promote our...
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Design Transfer Specialist
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Design Transfer Specialist
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Design Transfer Specialist
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Glasgow, Glasgow City, United Kingdom Cure Talent Full timeMedical Device Design Transfer Lead **About the Role** Cure Talent is partnering with a specialist agency to find a Design Transfer Lead to spearhead the transition of medical devices from design to manufacturing. The ideal candidate will have a strong understanding of medical device design transfer processes and experience in managing cross-functional...
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Design Transfer Specialist
7 days ago
Glasgow, Glasgow City, United Kingdom Cure Talent Full timeMedical Device Design Transfer Lead **About the Role** Cure Talent is partnering with a specialist agency to find a Design Transfer Lead to spearhead the transition of medical devices from design to manufacturing. The ideal candidate will have a strong understanding of medical device design transfer processes and experience in managing cross-functional...
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Design Transfer Specialist
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Glasgow, Glasgow City, United Kingdom Cure Talent Full timeMedical Device Design Transfer Lead **About the Role** Cure Talent is partnering with a specialist agency to find a Design Transfer Lead to spearhead the transition of medical devices from design to manufacturing. The ideal candidate will have a strong understanding of medical device design transfer processes and experience in managing cross-functional...
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