Regulatory and Start Up Specialist
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Job Description
Regulatory and Start Up Specialist enabling clinical trial approvals and site activation for Precision for Medicine. Managing Spanish submissions, contracts, budgets, and essential documents.
Responsibilities:
- Deliver timely, high-quality site activation readiness for assigned country/sites and foresee and mitigate risks
- Prepare Clinical Trial Application forms and submission dossiers for Competent Authorities, Ethics Committees, and other local bodies
- Interact with Competent Authorities and Ethics Committees and handle responses
- Provide 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 site CRA to align communication and secure site activation
- Review and manage essential documents 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 teams
- Maintain site-level critical path data for regulatory timelines, contracts, budgets, and required reviews
- Support study budget negotiations and execution of investigator contracts
- Support feasibility site outreach
- Maintain knowledge of local clinical trial laws and regulations and share knowledge within PFM
- Maintain audit/inspection readiness and file documents in the relevant TMF
- Support Pre-Study Site Visits when required
Requirements:
- Bachelor’s degree in life sciences or related field, or Registered Nurse (RN) or equivalent combination of education, training, and experience
- Demonstrated experience in contracts and budgeting negotiation
- Previous experience working 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
- Fluency in English and Spanish
- Qualification in Pharmacy or work experience as a Pharmacist highly beneficial
- Relevant regulatory and site start-up experience preferred
- Experience using milestone tracking tools/systems preferred
- Advanced degree, RAC certification, or Masters in Regulatory Science preferred
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