Specialist, Study Start Up – 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 SSU RA management plan.

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

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

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

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

• Investigate any incomplete, incorrect, or missing documentation.

• Generate reports and updates for the study team regarding the status of essential documents.

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

• Manage site outreach and oversee confidential disclosure agreements.

• Coordinate the documentation and tasks necessary for investigational product release, site activation, and initiation.

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

• Organize and evaluate translations of essential documents.

• Contribute to the development of regulatory and study start-up strategies and plans.

• Complete project trackers, maintain study portals, and perform TMF filing and submission dossier quality control.

• Ensure deliverables and submissions of essential documents align with project timelines, expectations, SOPs, and study-specific criteria.

⛳️ Requirements

• A graduate 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 responsibility.

• Excellent written and verbal communication abilities.

• Proficiency in English, both written and spoken.

🏝️ Benefits

• Remote work opportunities.

• A collaborative, international team environment.

• Opportunities for career advancement.

• Emphasis on work-life balance.

• A supportive organizational culture.

• Chance to collaborate with experts in clinical research, pharmacovigilance, and quality consulting.