Global Study Start-Up & Regulatory Affairs Lead

Ergomed Group; Kraków; Hybrid; PLN 290,000 - 360,000; Full time

Job summary

Ergomed Group is seeking a Study Start Up and Regulatory Affairs Specialist with 2+ years of experience to drive regulatory readiness and site initiation for complex trials. The role acts as a liaison across internal teams, clients, and sites, ensuring compliant and timely start-up activities.

You will draft and review essential documents, coordinate translations, and steer regulatory strategies across selected regions.

Qualifications

• Graduate degree in Chemistry or Life Sciences, Nursing or equivalent combination of education and experience.
• Minimum 2 years within pharmaceutical or CRO industry or Regulatory body.
• Good knowledge of ICH GCP and national regulations for territories of competency.

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.
• Handles medium-complexity regulatory environments, including multi-country requirements where applicable.
• 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 (including submissions, essential documents, and translations) to ensure completeness, accuracy, and compliance with ICH-GCP and country-specific requirements.
• Responsible for drafting, negotiating, finalizing, and executing clinical site agreements, ancillary agreements as well as amendments at country or regional level, in accordance with project requirements and country regulations and within the projected delivery timelines
• Review all relevant documentation e.g. labels, patient information sheets, diary cards, insurance etc, to ensure compliance with ICH GCP & country specific requirements.
• Contribute towards the preparation and/or review of complex technical/scientific/legal documentation.
• Arrange for and/or review translation of essential documents as required
• Provide regulatory/SSU strategic input to internal and external customers. Develop the regulatory strategy and the SSU Plan, joint operating procedures and core documents
• Promptly identify and escalation risk/potential risk to the project team which may jeopardise deliverables; support corrective/preventive actions
• Performs other work-related duties as assigned.

Skills

Regulatory affairs

SSU planning

ICH-GCP

Multi-country

Education

Graduate degree in Chemistry or Life Sciences

Job description

Ergomed Group is seeking a Study Start Up and Regulatory Affairs Specialist with 2+ years of experience to drive regulatory readiness and site initiation for complex trials. The role acts as a liaison across internal teams, clients, and sites, ensuring compliant and timely start-up activities.

You will draft and review essential documents, coordinate translations, and steer regulatory strategies across selected regions.