Study Start Up and Regulatory Affairs Specialist

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

📋 Description

• Lead and oversee activities necessary for achieving site initiation readiness.

• Offer subject matter expertise while ensuring compliance with regulations.

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

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

• Make independent decisions regarding regulatory processes and documentation methods.

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

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

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

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

• Contribute to the preparation and review of complex technical, scientific, and legal documentation.

• Organize and/or review translations of essential documents.

• Provide strategic regulatory and study start-up input to both internal and external customers.

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

• Identify and escalate risks that may threaten deliverables and assist in implementing corrective/preventive measures.

• Perform other assigned work-related responsibilities.

⛳️ Requirements

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

• Prior experience in the pharmaceutical or CRO industry, or with a regulatory body.

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

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

• Subject matter expertise in study start-up and regulatory affairs.

• Capability to manage medium-complexity regulatory environments, including multi-country requirements.

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

• Knowledge of clinical site agreements and ancillary agreements.

• Ability to review labels, patient information sheets, diary cards, insurance, and related documentation for compliance.

• Understanding of technical, scientific, and legal documentation.

• Capacity to provide strategic input on regulatory/SSU matters.

• Ability to identify and escalate project risks, while supporting corrective/preventive actions.

🏝️ Benefits

• Flexible/remote work arrangements.

• Emphasis on work-life balance.

• Collaborative international team environment.

• Opportunities for career growth.

• Trusted ownership and agility to make a significant impact.

• Supportive workplace culture.

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

• Diverse and inclusive workplace where every voice is valued.