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

• Lead and oversee activities necessary to ensure site initiation readiness.

• Provide expertise in subject matter and guarantee adherence to regulatory requirements.

• Act as a bridge among internal teams, clients, and external stakeholders.

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

• Make autonomous decisions regarding regulatory processes and documentation strategies.

• Manage medium-complexity regulatory landscapes, including multi-country requirements.

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

• Prepare, review, and conduct 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 country-specific regulations.

• 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, SSU plans, joint operating procedures, and core documentation.

• Identify and escalate project risks while supporting corrective and preventive actions.

• Carry out other work-related tasks as assigned.

⛳️ Requirements

• Master's 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 areas of expertise.

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

• Capability to lead study start-up and regulatory activities for assigned countries or medium complexity projects.

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

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

• Insight into labels, patient information sheets, diary cards, insurance, and related compliance documentation.

• Ability to contribute to complex technical, scientific, or legal documentation.

• Capacity to provide regulatory/SSU strategic input and formulate regulatory strategies, SSU plans, joint operating procedures, and core documents.

🏝️ Benefits

• Options for remote work.

• Emphasis on work-life balance.

• A collaborative, international team environment.

• Opportunities for career advancement.

• Early ownership of responsibilities.

• A passionate and collaborative team of experts.

• An inclusive workplace where every voice is valued.