Principal Regulatory and Start Up Specialist

TL;DR

Principal Regulatory and Start Up Specialist (Clinical Research): Delivery of site activation readiness within assigned country/sites in Turkey, driving country-level submissions and site activation processes with an accent on timeliness, quality, and risk mitigation. Focus on preparing clinical trial application dossiers, interacting with CA/EC authorities, and coordinating translations and essential documents for approvals per ICH-GCP and local regulations.

Remote, Turkey. Fluency in English and Turkish required.

Company

Precision for Medicine is a Clinical Research Organization enabling precision medicine through integrated clinical trial designs, operational expertise, biomarker analytics, with focus on rare diseases, oncology, and other therapeutic areas.

What you will do

• Drive country-level submissions and site activation by coordinating multiple RSSs, preparing dossiers for CA/EC approvals.
• Interact with CA/EC, handle responses, provide updates to leads and project teams.
• Maintain project plans, trackers, regulatory intelligence; develop startup plans and IMP release criteria.
• Partner with site CRA for alignment, manage essential documents, customize ICFs, facilitate translations.
• Act as SME for site activation data, support budget/contract negotiations, ensure audit readiness.
• Mentor staff, support process improvements, client interactions, and feasibility activities.

Requirements

• Bachelor’s degree in life sciences or related field (or RN equivalent).
• 5+ years as Regulatory or Startup specialist in CRO/pharma/biotech.
• Fluency in English and Turkish.
• Excellent communication, organizational skills; experience with computerized systems.
• Knowledge of ICH-GCP and regulatory requirements; ability to prioritize and drive cross-functional activities.

Nice to have

• Relevant regulatory/site startup experience in Turkey (feasibility, contracts, submissions).
• Experience with milestone tracking tools; ability to assist juniors.
• Advanced degree (MD, PhD, PharmD)/RAC certification; Masters in Regulatory Science.

Culture & Benefits

• Appreciate employee contributions with input valued and nurtured for positive change.
• Equal Opportunity Employer; occasional travel may be required.
• Growing organization focused on groundbreaking cancer therapies and precision medicine.