Start-Up Associate Contractor

Allucent

. Coordinate and perform local site start-up activities for clinical studies.

Posted 10/3/2026full-timeSofia • BulgariaJuniorMid-LevelWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in regulatory affairs, including the preparation and submission of regulatory and ethical documentation for clinical trials. Proficient in contract negotiation and maintaining compliance with local and international regulatory requirements.

Highest-signal resume keywords

Regulatory Affairs ExperienceContract NegotiationClinical Trial Management System (CTMS)Life Science DegreeFluent in Bulgarian and English

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Regulatory Documentation PreparationClinical Trial Agreement (CTA) PreparationEssential Document Package CompilationSubmission to IEC/IRBDrug Development Process KnowledgeCountry-Specific Regulatory RequirementsData Tracking in CTMSFiling Documents in (e)TMFMonitoring Regulatory UpdatesInteracting with Regulatory Authorities

Soft Skills

Attention to DetailTeam CollaborationOral and Written Communication Skills

Tools & Technologies

Clinical Trial Management System (CTMS)(e)TMF

Certifications & Qualifications

Life Science Degree or Equivalent Qualification

Industry Keywords

Pharmaceutical IndustryBiotechnology IndustryRegulatory AffairsClinical StudiesEthical DocumentationSite-Contract Processes

About the role

Key responsibilities & impact

Coordinate and perform local site start-up activities for clinical studies.
Track start-up information, data, progress, milestones, and planned dates in CTMS and/or other tracking tools.
File and assist with filing documents in the (e)TMF.
Prepare, compile, submit, and maintain regulatory documentation for local clinical-trial authorities.
Provide compliant documents and support review of technical, pre-clinical, and clinical reports.
Interact with regulatory authorities and prepare responses to agency questions.
Monitor regulatory updates and communicate changes to relevant stakeholders.
Prepare, submit, and maintain ethical documentation for IEC/IRB requirements.
Interact with IEC/IRB and prepare responses to questions.
Adapt country SIS/ISF to site-specific requirements.
Provide country-specific requirements affecting site-contract processes.
Prepare, review, negotiate, and finalize CTAs, LOIs, termination letters, budgets, and other site-level agreements.
Communicate contract status with sites and internal personnel.
Arrange translations and obtain required site and Sponsor/Allucent signatures.
Prepare site-specific Essential Document Packages and send them to sites.
Collect and initially review Essential Documents and resolve discrepancies.
Obtain authorization for shipment of Investigational Product to sites.
Track relevant information and data in CTMS or other tracking tools.

Requirements

What you’ll need

Life Science degree or equivalent qualification or certification in a related allied health profession from an appropriate accredited institution.
More than 5 years of experience in regulatory affairs in the pharmaceutical or biotechnology industry.
Experience with contract negotiation.
Thorough knowledge of country or region competent authority submission and reporting requirements and guidelines.
Thorough understanding of the drug development process.
Fluent in Bulgarian and English, with good oral and written communication skills.
Attention to detail.
Ability to perform well as a team member.