Specialist, Study Start Up & Regulatory Affairs

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

📋 Description

• Execute study start-up and regulatory tasks according to a defined SSU RA management plan.

• Act as a communication link among SSU/regulatory project teams, regulatory bodies, vendors, and research sites.

• Independently oversee low-complexity study start-up activities with guidance from senior team members.

• Prepare, gather, review, and submit regulatory documentation to national authorities and ECs/IRBs.

• Collect, examine, and monitor essential documents necessary for study start-up and site activation.

• Investigate any incomplete, inaccurate, or missing documentation.

• Create reports and updates for the study team regarding document collection, review, and approval status.

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

• Manage site outreach and handle confidential disclosure agreements.

• Coordinate document processing in collaboration with study teams, sponsors, clinical monitoring, clinical contracts, and other functions.

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

• Organize and/or review translations of essential documents.

• Contribute to regulatory strategies, study start-up strategies, and SSU planning.

• Maintain project trackers, manage study portal and TMF filing, and ensure quality control of submission dossiers.

• Ensure that deliverables and essential document submissions align with project timelines, expectations, SOPs, and study-specific requirements.

⛳️ Requirements

• A graduate degree in Chemistry, Life Sciences, Pharmacy, MD, or an equivalent combination of education and experience.

• Prior experience in the pharmaceutical or CRO industry.

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

• Excellent written and verbal communication abilities.

• Proficiency in English, both written and spoken.

🏝️ Benefits

• Availability of remote work options.

• Emphasis on work-life balance.

• Collaborative environment within an international team.

• Opportunities for career advancement.

• Trusted ownership and flexibility in work.

• A passionate and collaborative team of experts.

• Chance to contribute to delivering safe and effective pharmaceutical treatments to patients globally.