Study Start Up and Regulatory Affairs Specialist

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

📋 Description

• Oversee and coordinate tasks necessary to ensure site initiation readiness.

• Offer expertise in the subject matter and guarantee adherence to regulatory standards.

• Communicate effectively with internal teams, clients, and external stakeholders.

• Achieve designated study start-up and regulatory objectives within established parameters.

• Make autonomous decisions regarding regulatory processes and documentation strategies.

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

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

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

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

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

• Organize and/or review translations of essential documents.

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

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

• Identify and escalate project risks, supporting corrective and preventive measures.

• Perform additional work-related tasks as assigned.

⛳️ Requirements

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

• Prior experience in the pharmaceutical or CRO sectors or within a regulatory agency.

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

• Comprehensive knowledge of specific country requirements related to SSU/Regulatory execution across multiple European and/or American countries.

• Experience managing regulatory environments of moderate complexity and multi-country specifications.

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

• Understanding of clinical site agreements and ancillary agreements.

• Knowledge of labels, patient information sheets, diary cards, and insurance documentation.

• Capability to provide strategic input for regulatory/SSU matters.

• Proficiency in developing regulatory strategies, SSU plans, joint operating procedures, and core documents.

🏝️ Benefits

• Full-time employment.

• Remote work options.

• Collaborative international team environment.

• Opportunities for career advancement.

• Flexible work-life balance.

• Chance to make a significant impact in clinical research for rare diseases and oncology.

• Dedicated and collaborative team of experts in clinical research, pharmacovigilance, and quality consulting.