Study Start Up and Regulatory Affairs Specialist

This is a fully remote position, open to applicants in Czechia.

📋 Description

• Oversee and coordinate the necessary activities to ensure site initiation readiness.

• Offer subject matter expertise while ensuring adherence to regulatory requirements.

• Serve as a liaison among internal teams, clients, and external stakeholders.

• Achieve assigned study start-up and regulatory milestones within the defined scope.

• Manage medium-complexity regulatory environments, including multi-country requirements as needed.

• Direct study start-up and regulatory activities for designated countries or projects of medium complexity.

• Prepare, review, and ensure the quality of regulatory and study start-up documentation, which includes submissions, essential documents, and translations.

• Draft, negotiate, finalize, and execute clinical site agreements, ancillary agreements, and amendments at the country or regional level.

• Assess labels, patient information sheets, diary cards, insurance, and other documentation for compliance with ICH-GCP and country-specific regulations.

• Assist in the preparation and/or review of intricate technical, scientific, and legal documentation.

• Organize and/or review translations of essential documents.

• Provide strategic regulatory and study start-up insights to both internal and external stakeholders.

• Develop regulatory strategies, study start-up plans, joint operating procedures, and core documents.

• Identify and escalate risks that could hinder project deliverables and support corrective or preventive measures.

• Undertake other job-related duties as assigned.

⛳️ Requirements

• A graduate degree in Chemistry, Life Sciences, Nursing, or an equivalent combination of education and experience.

• A minimum of 2 years of experience in the pharmaceutical or CRO industry, or with a regulatory body.

• Strong knowledge of ICH GCP and national regulations relevant to areas of competency.

• Solid understanding of country-specific requirements related to study start-up and regulatory delivery in multiple countries across Europe and/or the Americas.

• Capability to lead study start-up and regulatory activities for assigned countries or medium-complexity projects.

• Familiarity with regulatory and study start-up documentation, submissions, essential documents, and translations.

• Understanding of clinical site agreements, ancillary agreements, and amendments.

• Knowledge of labels, patient information sheets, diary cards, insurance, and related documentation.

• Ability to contribute to complex technical, scientific, and legal documentation.

• Knowledge of regulatory and study start-up strategic planning.

• Skill to identify and escalate project risks and assist in corrective/preventive actions.

• Capacity to make independent decisions within the assigned scope regarding regulatory processes and documentation methodologies.

🏝️ Benefits

• Option for remote work.

• Emphasis on work-life balance.

• Collaborative international team environment.

• Opportunities for career advancement.

• Chance to take ownership early in projects.

• Supportive workplace culture.

• Enthusiastic and collaborative team of experts.

• Values-driven work environment.

• Opportunity to contribute to the development of safe and effective pharmaceutical treatments for patients.