Regulatory and Site Start Up Specialist
Remote
Job Summary
Deliver site activation readiness and mitigate risks within assigned countries by preparing Clinical Trial Application Forms and submission dossiers for Competent Authorities and Ethics Committees. Coordinate interactions with regulatory bodies, manage translations, and customize informed consent forms while maintaining audit readiness and TMF compliance. Partner with site CRAs to secure document collection for activation and IMP release, facilitate feasibility site outreach, and support investigator contract negotiations. Maintain project trackers, regulatory intelligence tools, and local clinical trial law knowledge to ensure on-time site activation and regulatory leadership alignment.
Required Qualifications
- 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
- Experience using computerized information systems, electronic spreadsheets, word processing and electronic mail
- Fluency in English
Desired Qualifications
- A qualification in Pharmacy/ work experience as a Pharmacist would be highly beneficial
- Relevant regulatory and site start-up (feasibility, contract negotiations, CA/ EC/ IRB submissions) experience
- Experience using milestone tracking tools/systems
- Ability to prioritize workload to meet deadlines
- Advanced degree in medical or life sciences (MD, PhD, PharmD)/RAC certification/Masters in Regulatory Science
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