Global Regulatory Affairs Specialist
hace 5 días
Ergomed Group is a rapidly expanding full-service CRO specializing in Oncology and Rare Disease. Our company offers employee visibility, creative contribution, and realistic career development in an international culture that values employee experience, well-being, and mental health.
About the RoleWe are seeking a highly skilled Global Regulatory Affairs Specialist to join our team. As a key member of our Study Start-up and Regulatory team, you will be responsible for completing study start-up and regulatory deliverables based on established management plans. Your primary focus will be on serving as a liaison between project teams, authorities, vendors, and investigative sites to plan, organize, and execute SSU and regulatory deliverables in line with project, corporate, and industry regulatory strategies.
Key Responsibilities:- Support the SSU/Regulatory Lead in meeting project-specific submission/approval timelines and provide clear rationale for delays and contingency plans to mitigate impact.
- Anticipate and identify site issues during the start-up process and resolve minor to moderate issues independently.
- Prepare, collect, review, and track essential documents to facilitate efficient site initiation and activation, ensuring compliance with applicable regulations.
- Investigate incomplete, inaccurate, or missing documents to ensure accuracy and completeness of information.
- Prepare study team reports or updates regarding the status of essential document collection, review, and approval.
- Correspond actively with selected sites for updates regarding essential document completion, Informed Consent Form (ICF) development, and regulatory/submissions/approvals.
- Participate in ICF development, review, negotiation, and approval processes.
- Coordinate with study teams, sponsors, clinical monitoring, clinical contracts, and other functional areas on the priority and processing of documents leading to investigational product release, site activation, and site initiation.
- Support feasibility, site identification, and site documents customization as needed, closely following up with investigative sites for updates/resolution.
The ideal candidate should have strong knowledge of regulatory affairs principles and practices, with excellent communication and interpersonal skills. You should be proficient in preparing, collecting, reviewing, and tracking essential documents, as well as anticipating and resolving site issues during the start-up process.
What We OfferWe offer a competitive salary of $110,000 per annum, plus benefits, including a comprehensive health insurance plan, retirement savings plan, and generous paid time off. Our company prioritizes employee well-being and mental health, offering access to employee assistance programs and professional development opportunities.
Please note that the estimated salary range may vary based on location, experience, and qualifications. If you are a motivated and detail-oriented individual looking to advance your career in regulatory affairs, we encourage you to apply.
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