Global Study Start-Up & Regulatory Lead

Remote Jobs; United States; Remote; USD 110,000 - 160,000; Full time

Job summary

Ergomed Group is seeking a Specialist, Study Start Up and Regulatory Affairs to lead and coordinate activities ensuring site initiation readiness across assigned regions. You will provide expert regulatory input and ensure compliance with ICH-GCP and country-specific requirements.

You will draft, review, and manage regulatory submissions, site agreements, translations, and essential documents while guiding internal teams, clients, and external stakeholders to timely delivery.

Qualifications

• Graduate degree in Chemistry or Life Sciences, Nursing or equivalent combination of education and experience
• Previous experience within pharmaceutical or CRO industry or Regulatory body
• Good knowledge of ICH GCP and national regulations for territories of competency
• Good understanding of specific country requirements pertaining to SSU/Regulatory delivery in multiple countries within Europe and/or the Americas

Responsibilities

• Accountable for delivery of assigned study start-up and regulatory milestones within defined scope.
• Make independent decisions within assigned scope regarding regulatory processes and documentation approaches.
• Leads study start-up and regulatory activities for assigned countries or projects of medium complexity, ensuring delivery in line with timelines, quality standards, and regulatory requirements.
• Leads preparation, review, and quality control of regulatory and study start-up documentation to ensure completeness, accuracy, and compliance with ICH-GCP and country-specific requirements.
• Draft, negotiate, finalize, and execute clinical site agreements, ancillary agreements as well as amendments at country or regional level.
• Review related documentation to ensure compliance with ICH GCP & country-specific requirements.
• Provide regulatory/SSU strategic input to internal and external customers. Develop the regulatory strategy and the SSU Plan, joint operating procedures and core documents.
• Identify and escalate risks to the project team; support corrective/preventive actions.

Skills

Regulatory expertise

ICH GCP knowledge

Regulatory delivery (multi-country)

Pharma/CRO experience

Education

Graduate degree in Chemistry or Life Sciences, Nursing or equivalent combination of education and experience

Job description

Ergomed Group is seeking a Specialist, Study Start Up and Regulatory Affairs to lead and coordinate activities ensuring site initiation readiness across assigned regions. You will provide expert regulatory input and ensure compliance with ICH-GCP and country-specific requirements.

You will draft, review, and manage regulatory submissions, site agreements, translations, and essential documents while guiding internal teams, clients, and external stakeholders to timely delivery.