Regulatory and Site Start-Up Specialist
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Job Description
Regulatory specialist supporting clinical trial submissions and site activation for Precision for Medicine, a life sciences CRO. Managing essential documents, ethics approvals, contracts, and country-specific regulatory requirements.
Responsibilities:
- Deliver timely and high-quality site activation readiness within assigned country/sites while identifying and mitigating risks
- Prepare Clinical Trial Application Forms and submission dossiers for Competent Authorities, Ethics Committees, IRBs, 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 CRAs to align communication and secure site collaboration
- Prepare, review, and manage essential documents required for site activation and IMP release
- Customize country/site-specific Patient Information Sheets and Informed Consent Forms
- Facilitate document translations and coordinate translation activities
- Coordinate with Feasibility, Clinical Operations, Project Management, Regulatory, and Site Contracts teams
- Act as subject matter expert for site-level critical path and Site Activation data points
- Support study budget negotiations and investigator contract execution when required
- Support feasibility site outreach when needed
- Maintain knowledge of local clinical trial laws and regulations and distribute knowledge within Precision for Medicine
- Maintain audit/inspection readiness and file documents according to TMF or study-specific plans
- Support Pre-Study Site Visits when needed
- Support process improvement initiatives, training, and mentoring
- Perform other duties assigned by management
Requirements:
- Bachelor’s degree in life sciences or related field (ideally in a scientific or healthcare discipline), or Registered Nurse (RN) or equivalent combination of education, training, and experience
- 1 year or more as a Regulatory or SU specialist (or comparable role) in either a CRO or pharmaceutical/ biotech industry or equivalent, relevant experience and/or demonstrated competencies
- Strong communication and organizational skills are essential
- Experience using computerized information systems, electronic spreadsheets, word processing and electronic mail required
- Fluency in English and for non-English speaking countries the local language of country where position based
- Relevant regulatory and site start-up (feasibility, contract negotiations, CA/ EC/ IRB submissions) experience for the particular country preferred
- Experience using milestone tracking tools/systems preferred
- Ability to prioritize workload to meet deadlines preferred
- Advanced degree in medical or life sciences (MD, PhD, PharmD)/RAC certification/Masters in Regulatory Science preferred
Benefits:
- Equal Opportunity Employer
- Reasonable accommodation available for applicants with disabilities
- AI-generated insights during the application journey, including resume review and interviews, with opt-out option
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