Study Start Up and Regulatory Affairs Specialist

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

📋 Description

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

• Provide expertise in the subject matter while ensuring compliance with regulations.

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

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

• Make independent decisions concerning regulatory procedures and documentation strategies.

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

• Prepare, review, and perform quality control on regulatory and study start-up documents, including submissions, essential documents, and translations.

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

• Review labels, patient information sheets, diary cards, insurance, and related documents for compliance.

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

• Organize and assess translations of essential documents.

• Offer strategic regulatory and study start-up insights to internal and external clients.

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

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

• Carry out other assigned work-related responsibilities.

⛳️ Requirements

• Graduate degree in Chemistry, Life Sciences, Nursing, or a relevant 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 within areas of expertise.

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

• Experience managing multi-country regulatory obligations.

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

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

• Proficient in drafting, negotiating, finalizing, and executing clinical site and ancillary agreements.

• Understanding of ICH-GCP and compliance requirements specific to various countries.

🏝️ Benefits

• Flexible and remote working options.

• Emphasis on work-life balance.

• Collaborative environment with an international team.

• Opportunities for career advancement.

• Trusted autonomy and a chance to make a significant impact.

• A passionate and collaborative team of specialists.

• A diverse and inclusive workplace where every opinion matters.