Full-Time Specialist Regulatory Affairs/Start-up

Specialist/Senior Specialist, Study Start Up and Regulatory is responsible for completing study start-up and regulatory deliverables.

Serves as a liaison between SSU/regulatory project team, authorities, vendors, and investigative sites in planning, organizing, and executing SSU and regulatory deliverables following project, corporate, and industry regulatory strategies.

1. Support the SSU/Regulatory Lead to project site-specific submission/approval timelines and ensure they are met; if timelines are not met, provide clear rationale for delays and contingency plans.
2. Anticipate and identify site issues during start-up process and resolve minor to moderate issues independently.
3. Prepare, collect, review regulatory information and documents to support submissions to FDA, EMA, and national authorities (CTA/INDs, MAAs/NDAs/BLAs, ODDs, PIPs) as well as Ethic Committees/IRBs.
4. Collect, review, and track essential documents to facilitate efficient site initiation and activation. Investigate incomplete, inaccurate or missing documents.
5. Prepare study team reports or updates regarding essential document collection, review, and approval.
6. Actively correspond with sites for updates regarding essential document completion, Informed Consent Form (ICF) development, and regulatory/EC submissions/approvals.
7. Participate in ICF development, review, negotiation, and approval processes.
8. Coordinate with study teams, sponsors, clinical monitoring, clinical contracts, or other functional areas on the priority and processing of documents.
9. Support feasibility, site identification, and site documents customization (e.g., informed consent document).
10. Arrange for and/or review translation of essential documents.
11. Ensure all relevant essential documents are submitted to Trial Master File (TMF) in a timely manner.

Qualifications:

• Bachelor’s degree in a science-related field or equivalent.
• Experience in the pharmaceutical, biotechnology, or CRO industry.
• Knowledge of clinical trials process.
• Previous experience in Clinical Trial Regulatory submissions.
• Excellent oral and written communication skills.
• Excellent interpersonal and organizational skills.
• Good customer/client relationship management.
• Proactive problem-solving skills.
• Knowledge of clinical research principles, methods, and procedures.
• Good computer skills (MS Word, Excel, PowerPoint, Outlook).
• Experience with ICH/GCP documentation and process (preferred).
• Ability to assess, coordinate, and organize/reorganize workload.

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