Specialist, Study Start Up and Regulatory Affairs

This is a fully remote position, open to applicants in Serbia.

📋 Description

• Execute study start-up and regulatory tasks in accordance with the defined SSU RA management strategy.

• Collaborate with SSU/regulatory project teams, relevant authorities, vendors, and investigative sites.

• Manage low-complexity study start-up activities independently, guided by senior team members.

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

• Collect, review, and monitor essential documents required for site initiation and activation.

• Investigate any incomplete, inaccurate, or missing documentation.

• Generate reports and status updates for the study team.

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

• Conduct outreach to sites and manage confidential disclosure agreements.

• Coordinate documentation and priorities with study teams, sponsors, clinical monitoring, contracts, and other departments.

• Review labels, patient information sheets, diary cards, insurance documents, and other materials for compliance with ICH GCP and local regulations.

• Organize or review translations of essential documents.

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

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

• Complete deliverables within project timelines and submit essential documents to the TMF as per SOPs and study requirements.

⛳️ Requirements

• Master's degree in Chemistry or 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 relevant to the areas of expertise.

• Excellent written and verbal communication skills.

• Proficiency in English, both in writing and speaking.

🏝️ Benefits

• Option for remote work.

• Opportunities for employee visibility and creative contributions.

• Realistic career advancement prospects.

• Exposure to an international work culture.

• Support for employee well-being and mental health.

• Promotion of a healthy work-life balance.