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 facilitate the necessary activities to ensure site initiation readiness.

• Offer specialized knowledge and guarantee adherence to regulatory standards.

• Engage with internal teams, clients, and external stakeholders.

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

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

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

• Prepare, assess, and ensure quality control of regulatory and study start-up documents.

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

• Evaluate relevant documentation for compliance with ICH-GCP and specific national regulations.

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

• Organize and review translations of essential documents.

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

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

• Identify and escalate project risks while assisting in corrective and preventive measures.

• Execute other assigned work-related responsibilities.

⛳️ Requirements

• A graduate degree in Chemistry, Life Sciences, Nursing, 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 understanding of ICH GCP and national regulations relevant to the areas of expertise.

• Comprehensive knowledge of country-specific SSU/Regulatory requirements across various countries in Europe and/or the Americas.

• Familiarity with regulatory processes and documentation.

• Capability to work with regulatory and study start-up documentation, submissions, essential documents, and translations.

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

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

🏝️ Benefits

• Flexible remote working options.

• Support for work-life balance.

• Opportunity to collaborate with an international team.

• Potential for career advancement.

• Empowerment through trusted ownership and early responsibility.