Senior Specialist, Study Start Up – Regulatory Affairs

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

📋 Description

• Lead and manage the activities necessary to ensure site initiation readiness.

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

• Make autonomous decisions regarding regulatory processes and documentation methods.

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

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

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

• Collaborate with legal, finance, clinical operations, sponsors, monitors, and various functional teams.

• Conduct outreach to sites and act as the primary contact for assigned locations.

• Coordinate document processing that leads to investigational product release and site activation readiness.

• Review labels, patient information sheets, diary cards, insurance, and related documentation for compliance.

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

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

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

• Monitor project budgets and hours against the budget, escalating any out-of-scope work.

• Offer expert guidance to clients on complex regulatory inquiries and coordinate with authorities.

• Serve as a country or regional subject matter expert on regulatory and clinical study components.

• Maintain repositories of country intelligence and disseminate updates on regulatory changes.

• Complete project trackers, correspondence logs, study portal/TMF filing, and quality control for submission dossiers.

• Support business development proposals, budgets, and meetings.

• Adhere to SOPs, work instructions, training records, and timesheet protocols.

• Assist junior staff during audits and inspections.

• Contribute to the development of SOPs, working practices, and company initiatives.

• Train, coach, and mentor junior staff members.

• Perform other assigned duties as necessary.

⛳️ Requirements

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

• Prior experience in the pharmaceutical or CRO industry.

• Strong understanding of ICH GCP and national regulations in relevant territories.

• Proficiency in English, both written and spoken.

• Effective written and verbal communication abilities.

• Exceptional planning and organizational skills.

• Strong capabilities in planning, strategizing, managing, monitoring, scheduling, problem-solving, and critiquing.

• Ability to manage multiple responsibilities, prioritize tasks, and adjust to shifting work assignments.

• Capacity to exercise sound judgment and make independent decisions.

• Remarkable attention to detail.

• Excellent self-motivation and ability to motivate others.

🏝️ Benefits

• Work-life balance.

• Collaborative, international team environment.

• Career growth opportunities.

• Trusted to take ownership early in projects.

• Passionate and collaborative team of experts.

• Opportunities for training, coaching, and mentoring.