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 manage all tasks necessary for achieving readiness for site initiation.

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

• Act as a primary point of contact among internal teams, clients, and external stakeholders.

• Achieve assigned study start-up and regulatory goals within the specified scope.

• Make autonomous decisions concerning regulatory procedures and documentation methods.

• Manage regulatory environments of medium complexity, including requirements across multiple countries.

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

• Prepare, examine, and ensure the quality of regulatory and study start-up documents, which include submissions, essential documents, and translations.

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

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

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

• Organize and/or review translations of essential documents.

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

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

• Identify and raise project risks while supporting corrective and preventive measures.

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

• Solid comprehension of specific country requirements related to study start-up and regulatory delivery across multiple countries in Europe and/or the Americas.

🏝️ Benefits

• Full-time employment.

• Remote work opportunities.

• Collaborative environment with an international team.

• Opportunities for career advancement.

• Flexible work-life balance.

• Chance to positively impact patient care and pharmaceutical treatments.

• A diverse and inclusive workplace where every voice is valued.