Study Start Up and Regulatory Affairs Specialist, 2 years plus experience

This is a fully remote position, open to applicants in New Zealand, +1 more country.

📋 Description

• Oversee and coordinate activities necessary for achieving site initiation readiness.

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

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

• Accomplish assigned study start-up and regulatory milestones within the established scope.

• Make autonomous decisions concerning regulatory processes and documentation strategies.

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

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

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

• Review labels, patient information sheets, diary cards, insurance documents, and other materials for ICH-GCP and country-specific compliance.

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

• Organize and/or assess translations of essential documents.

• Provide strategic input for 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/preventive measures.

• Execute other assigned work-related responsibilities.

⛳️ Requirements

• Advanced degree in Chemistry or Life Sciences, Nursing, or a comparable combination of education and experience.

• At least 2 years of experience in the pharmaceutical or CRO industry or within a regulatory body.

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

• Solid understanding of specific country requirements related to SSU/Regulatory delivery across multiple countries within Europe and/or the Americas.

• Experience in managing medium-complexity regulatory environments and multi-country obligations.

🏝️ Benefits

• Availability of remote work.

• Emphasis on work-life balance.

• Engaging, collaborative international team atmosphere.

• Opportunities for career advancement.

• Trusted responsibility and flexibility.

• Chance to work alongside experts in clinical research, pharmacovigilance, and quality consulting.