Regulatory and Start Up Specialist, Portuguese Speaker
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Job Description
Regulatory and Start Up Specialist enabling clinical trial site activation in Spain for Precision for Medicine, a global clinical research organization. Managing submissions, contracts, budgets, and essential documents.
Responsibilities:
- Deliver timely and high-quality site activation readiness for assigned countries/sites and identify and mitigate risks
- Prepare Clinical Trial Application forms and submission dossiers for Competent Authorities, Ethics Committees, and other applicable local bodies
- Interact with Competent Authorities and Ethics Committees and handle responses
- Provide regular submission updates to Start Up/Regulatory Leads and Project Managers/Project Teams
- Maintain project plans, trackers, and regulatory intelligence tools
- Support study-specific start-up plans, IMP release requirements, and essential document review criteria
- Partner with assigned site CRA to align communication and secure site activation
- Review and manage essential documents required for site activation and IMP release
- Customize country/site-specific Patient Information Sheets and Informed Consent Forms
- Coordinate document translations
- Communicate with Feasibility, Clinical Operations, Project Management, Regulatory, and Site Contracts Management teams regarding project status and deliverables
- Act as subject matter expert for site-level critical-path-to-site-activation data points
- Support study budget negotiations and execution of investigator contracts when required
- Support feasibility site outreach when required
- Maintain knowledge of local clinical trial laws and regulations and share knowledge within Precision for Medicine
- Maintain audit and inspection readiness and file documents in the relevant TMF
- Support clinical teams performing Pre-Study Site Visits
Requirements:
- Based in Spain
- Bachelor’s degree in life sciences or related field, or Registered Nurse (RN), or equivalent combination of education, training, and experience
- Qualification in Pharmacy or work experience as a Pharmacist highly beneficial
- Demonstrated experience in contracts and budgeting negotiation, in addition to regulatory submissions experience
- Fluency in English and Portuguese
- Previous experience as a Regulatory or Start Up specialist in a CRO or pharmaceutical/biotech industry, or equivalent relevant experience and/or demonstrated competencies
- Strong communication and organizational skills
- Experience using computerized information systems, electronic spreadsheets, word processing, and electronic mail
- Relevant regulatory and site start-up experience preferred
- Experience using milestone tracking tools/systems preferred
- Advanced degree in medical or life sciences, RAC certification, or Master’s in Regulatory Science preferred
Benefits:
- Remote work arrangement in Spain
- Regular full-time employment
- Equal opportunity employment
- Reasonable accommodation available during the application process
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