Regulatory and Start Up Specialist
New
P
Precision for MedicineClinical Research
Remote, TurkeyFull-TimeSenior
Salary not disclosed
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Job Details
- Languages
- English, Turkish
- Experience
- 5 years or more as a Regulatory or SU specialist
- Required Skills
- Project Management
Requirements
- Bachelor's degree in life sciences, related scientific/healthcare discipline, or Registered Nurse (RN).
- 5+ years of experience as a Regulatory or Start-Up specialist in a CRO, pharmaceutical, or biotech industry.
- Fluency in both English and Turkish.
- Expertise in local clinical trial laws, regulations, and ICH-GCP principles.
- Experience with site start-up tasks including feasibility, contract negotiations, and CA/EC/IRB submissions.
- Strong proficiency in computerized information systems, spreadsheets, and word processing.
- Proven ability to drive cross-functional activities and coordinate team efforts.
- Excellent communication, organizational, and prioritization skills.
- Ability to work independently in a fast-paced environment.
- Experience with milestone tracking tools and systems.
Responsibilities
- Deliver site activation readiness within assigned country/sites and mitigate associated risks.
- Drive country-level submissions and coordinate site activation processes.
- Prepare Clinical Trial Application Forms and submission dossiers for regulatory authorities and ethics committees.
- Interact with regulatory bodies and handle responses to inquiries.
- Maintain project plans, trackers, and regulatory intelligence tools.
- Support development of start-up plans, IMP release requirements, and essential document review criteria.
- Partner with site CRAs to ensure communication alignment and site collaboration.
- Review and manage collection of essential documents for site activation and IMP release.
- Coordinate translation of submission documents and customize patient information sheets.
- Act as SME for site level critical path data points, including contracts, budgets, and local regulatory timelines.
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