Start-Up Associate II

Allucent

. Track relevant information, data, progress, and milestones in CTMS and/or other tracking tools for assigned Start-Up activities.

Posted 10/3/2026full-timeMilan • ItalyJuniorMid-LevelWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in regulatory affairs, including the preparation and submission of regulatory documentation and compliance with local regulations. Proficient in tracking and managing clinical trial milestones and documentation using CTMS and other tools.

Highest-signal resume keywords

Regulatory Affairs ExperienceCTMS ProficiencyClinical Trial DocumentationFluent in Italian and EnglishLife Science Degree

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Regulatory Documentation PreparationClinical Trial ManagementSubmission to Regulatory AuthoritiesEssential Document ManagementSite-Level Agreement NegotiationKnowledge of Drug Development ProcessCountry-Specific Regulatory RequirementsMonitoring Regulatory UpdatesFiling in (e)TMFCTAs and LOIs Preparation

Soft Skills

Attention to DetailTeam CollaborationOral and Written Communication

Tools & Technologies

CTMS(e)TMFTracking Tools

Certifications & Qualifications

Life Science Degree or Equivalent Qualification

Industry Keywords

Regulatory AffairsPharmaceutical IndustryBiotechnology IndustryClinical TrialsIEC/IRB Compliance

About the role

Key responsibilities & impact

Track relevant information, data, progress, and milestones in CTMS and/or other tracking tools for assigned Start-Up activities.
Ensure planned dates are reliable and up to date in CTMS departments/study teams.
File document-owner documents in the (e)TMF and assist other Study Start-up team members with filing.
Prepare, compile, submit, and maintain regulatory documentation for local clinical-trial regulatory agencies.
Provide documents compliant with local regulations and support review of technical, pre-clinical, and clinical reports for regulatory submissions.
Interact with regulatory authorities; prepare and submit responses to agency questions.
Monitor updates to regulations, guidelines, and procedures and communicate them as appropriate.
Support the Global Regulatory Manager and/or Global Submission Specialist as needed.
Prepare, compile, submit, and maintain local IEC/IRB ethical requirements and documentation.
Interact with IEC/IRB and prepare and submit 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 where applicable.
Obtain site and Sponsor/Allucent signatures as applicable.
Prepare site-specific Essential Document Packages and send them to sites.
Collect and conduct first review of Essential Documents; follow up on discrepancies until resolution.
Obtain authorization for shipment of Investigational Product to sites.
Track relevant information and data in CTMS and/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 2 years of experience in regulatory affairs in the pharmaceutical or biotechnology industry.
Thorough knowledge of the country or region competent authority submission and reporting requirements and guidelines.
Thorough understanding of the drug development process.
Good oral and written communication skills; fluent in Italian and English.
Attention to detail.
Able to perform well as a team member.

Benefits

Comp & perks

Comprehensive benefits package per location
Competitive salaries per location
Departmental Study/Training Budget for furthering professional development
Flexible Working hours (within reason)
Participation in our enriching Buddy Program as a new or existing employee
Internal growth opportunities and career progression
Financially rewarding internal employee referral program
Eligibility for our Spot Bonus Award Program in recognition of going above and beyond on projects
Eligibility for our Loyalty Award Program in recognition of loyalty and commitment of longstanding employees
In-office work policy prescribing 2 days in office per week for employees within reasonable distance from one of our global offices