Study Start Up and Regulatory Affairs Specialist

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

📋 Description

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

• Provide expert knowledge and guarantee adherence to regulatory standards.

• Act as the liaison among internal teams, clients, and external stakeholders.

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

• Make independent decisions regarding regulatory processes and documentation methods.

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

• Prepare, review, and ensure quality control of regulatory and study start-up documents, including submissions, essential papers, and translations.

• Draft, negotiate, finalize, and execute agreements for clinical sites, ancillary agreements, and amendments.

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

• Contribute to intricate technical, scientific, and legal documentation.

• Organize and/or review translations of essential documents.

• Provide strategic input on regulatory and study start-up processes.

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

• Identify and escalate project risks while supporting corrective and preventive actions.

• Perform additional work-related tasks as assigned.

⛳️ Requirements

• Graduate degree in Chemistry, Life Sciences, Nursing, or a related field, or an equivalent mix of education and experience.

• Prior experience in the pharmaceutical or CRO sector, or with a regulatory agency.

• Strong understanding of ICH GCP and national regulations relevant to areas of expertise.

• Good grasp of country-specific requirements for study start-up and regulatory processes across multiple countries in Europe and/or the Americas.

• Experience navigating regulatory environments and managing multi-country requirements.

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

• Knowledge of country-specific regulatory obligations and ICH-GCP compliance.

🏝️ Benefits

• Option for remote work.

• Emphasis on work-life balance.

• Collaborative environment with an international team.

• Opportunities for career advancement.

• Trusted ownership and flexibility in your role.

• Chance to contribute to the delivery of safe and effective pharmaceutical treatments to patients.

• Passionate and collaborative team of specialists.

• Inclusive workplace that values every voice.