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 expertise in the subject matter and ensure adherence to regulatory standards.

• Act as the intermediary between internal teams, clients, and external stakeholders.

• Accomplish designated study start-up and regulatory milestones within the specified scope.

• Make independent decisions related to regulatory processes and documentation strategies.

• Manage study start-up and regulatory tasks for assigned countries or projects of medium complexity.

• 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.

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

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

• Organize and/or review translations of essential documents.

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

• 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

• A graduate degree in Chemistry, Life Sciences, Nursing, or a related field, or an equivalent 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 the areas of responsibility.

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

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

• 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.

• Understanding of clinical site agreements, ancillary agreements, amendments, and country-specific regulations.

🏝️ Benefits

• Flexible and remote working arrangements.

• Emphasis on work-life balance.

• Collaborative environment with an international team.

• Opportunities for career advancement.

• Empowerment and autonomy in your role.

• Chance to contribute to impactful work that aids in delivering safe and effective pharmaceutical treatments to patients.