Regulatory and Start Up Specialist
P
Precision for MedicineClinical Research
Remote, TurkeyFull-TimeSenior
Salary not disclosed
Apply NowOpens the employer's application page
Job Details
- Languages
- English and Turkish
- Experience
- 5 years or more as a Regulatory or SU specialist
- Required Skills
- GCP
Requirements
- Bachelor’s degree in life sciences, healthcare, or equivalent experience (RN accepted).
- 5+ years of experience as a Regulatory or SU specialist in CRO or pharma/biotech.
- Fluency in English and Turkish.
- Experience using computerized information systems, spreadsheets, and word processing.
- Experience in driving cross-functional activities, coordination, and team oversight.
- Knowledge of GCP/ICH guidelines and local clinical trial regulations.
- Experience with site start-up, feasibility, contract negotiations, and CA/EC/IRB submissions.
- Experience using milestone tracking tools/systems.
Responsibilities
- Deliver site activation readiness for assigned country/sites.
- Drive country-level submissions and coordinate site activation processes.
- Prepare Clinical Trial Application forms and submission dossiers for local CA/EC.
- Manage essential document collection and IMP release requirements.
- Act as SME for site-level critical path to activation.
- Support negotiation of study budgets and execution of investigator contracts.
- Maintain audit readiness and documentation in TMF.
- Provide mentorship to staff on local country regulations and internal procedures.
View Full Description & ApplyYou'll be redirected to the employer's site
