Regulatory Affairs Specialist with Oncology Expertise
hace 5 días
Company Overview
Ergomed Group is a rapidly expanding, full-service CRO specializing in Oncology and Rare Disease. Since its foundation in 1997, the company has grown organically and strategically, with operations in Europe, North America, and Asia.
Job Summary
The Specialist/Senior Specialist, Study Start Up and Regulatory role involves completing study start-up and regulatory deliverables based on an established SSU RA management plan. This position serves as a liaison between SSU/regulatory project teams, authorities, vendors, and investigative sites in planning, organizing, and executing SSU and regulatory deliverables following project, corporate, and industry regulatory strategies.
Key Responsibilities
- Support SSU/Regulatory Leads in meeting project site-specific submission/approval timelines; provide clear rationale for delays and contingency plans to mitigate impact.
- Anticipate and identify site issues during start-up process; resolve minor to moderate issues independently.
- Prepare, collect, review regulatory information and documents to support submissions to FDA, EMA, and national authorities (CTA/INDs, MAAs/NDAs/BLAs, ODDs, PIPs) and Ethic Committees/IRBs for initial authorization and maintenance, in compliance with applicable regulations.
- Collect, review for completeness, and track essential documents to facilitate efficient site initiation and activation.
- Investigate incomplete, inaccurate, or missing documents to ensure accuracy and completeness of information.
- Prepare study team reports or updates regarding status of essential document collection, review, and approval.
- Actively correspond with selected sites for updates regarding essential document completion, Informed Consent Form (ICF) development, and regulatory/EC submissions/approvals.
- Participate in ICF development, review, negotiation, and approval processes.
- Coordinate with study teams, sponsors, clinical monitoring, clinical contracts, and/or other functional areas on priority and processing of documents leading to investigational product release, site activation, and site initiation.
- Support feasibility, site identification, and site documents customization (e.g., informed consent document) as needed, and closely follow up with investigative sites for updates/resolution.
Estimated Salary Range: $80,000 - $120,000 per year, depending on experience.
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