Regulatory Start‑Up Associate II

About the role

The Regulatory Start‑Up Associate II supports the planning, preparation and review of ethics and regulatory submissions for clinical trials during start‑up, maintenance and close‑out phases. You will ensure compliance with ICH‑GCP and local requirements, helping to secure timely trial approvals.

Key responsibilities

• Provide guidance on country‑specific regulations to RSMs/PMs.
• Prepare and submit Central EC/IRB, Local EC/Governance, regulatory authority and other required documents.
• Manage queries from ethics committees and regulatory authorities, ensuring prompt responses.
• Support amendments, safety reports, and other regulatory submissions throughout the study lifecycle.
• Customize Informed Consent Forms, coordinate translations and reviews.
• Assist site activation by collecting, reviewing and submitting essential documents.
• Collaborate with Clinical Contracts Specialists on budgets and CTA negotiations.
• Review clinical trial packaging and labeling for local compliance.
• Handle import/export licence applications and customs clearance when needed.
• Register trials on official registries and maintain up‑to‑date records.
• Maintain accurate regulatory information in trial management systems and ensure proper filing in the TMF.
• Escalate issues that may impact timelines and propose mitigation plans.

Required profile

• 1‑3 years of regulatory start‑up experience in clinical research or a related role.
• Degree in Clinical, Pharmacy, Life Sciences or a related field.
• Ability to work independently with general supervision.
• Strong organisational and time‑management skills with high attention to detail.

Required skills