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 tasks 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

• Successfully meet assigned study start-up and regulatory milestones within the established scope

• Make autonomous decisions concerning regulatory processes and documentation strategies

• Lead study start-up and regulatory initiatives for designated countries or medium-complexity projects

• Prepare, review, and perform quality control on regulatory and study start-up documents, 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 documents, and other materials for compliance with ICH-GCP and specific country regulations

• Arrange and/or oversee translations of essential documents

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

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

• Identify and escalate project risks while supporting corrective and preventive measures

• Perform additional work-related tasks as assigned

⛳️ Requirements

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

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

• Strong knowledge of ICH GCP and national regulations relevant to the areas of responsibility

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

• Familiarity with regulatory compliance and country-specific demands

• Capability to navigate medium-complexity regulatory environments and multi-country requirements

• Proficiency in handling regulatory and study start-up documentation, submissions, essential documents, and translations

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

• Competence in reviewing labels, patient information sheets, diary cards, insurance, and associated documentation

• Ability to contribute to intricate technical, scientific, and legal documentation

🏝️ Benefits

• Full-time employment

• Flexible work arrangements / remote work options

• Emphasis on work-life balance

• Collaborative, international team environment

• Opportunities for career advancement

• Empowerment through trusted ownership and the chance to make a meaningful impact

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