Senior Start-Up & Regulatory Specialist — Remote

Precision Medicine Group; Turkey; Remote; TRY 400,000 - 800,000; Full time

Job summary

Precision Medicine Group is seeking a (Senior) Start Up & Regulatory Specialist to join our team in Turkey, responsible for country-level regulatory submissions and site activation. You will collaborate with cross-functional teams to ensure timely and compliant startup activities in a fast-paced CRO setting.

The role requires fluency in English and Turkish, strong communication skills, and the ability to mentor junior staff while navigating local and international regulatory requirements.

Qualifications

• Bachelor's degree in life sciences or RN or equivalent and 5+ years in regulatory/start-up roles.
• Experience in CRO or pharma regulatory submissions and site start-up.
• Fluency in English and Turkish with strong communication skills.
• Ability to work independently and lead cross-functional teams.

Responsibilities

• Ensure site activation readiness and mitigate risks within assigned country/sites.
• Drive country-level submissions and site activation by coordinating activities across RSSs.
• Prepare Clinical Trial Applications and submission dossiers for CA, EC and local bodies.
• Interact with CA/EC and handle responses to regulatory authorities.
• Maintain project plans, trackers and regulatory intelligence tools.

Skills

Regulatory submissions

Stakeholder coordination

Regulatory affairs

Cross-functional leadership

Fluency in English and Turkish

Education

Bachelor's degree in life sciences or related field

Advanced degree in medical or life sciences (MD/PhD/PharmD)

Job description

Precision Medicine Group is seeking a (Senior) Start Up & Regulatory Specialist to join our team in Turkey, responsible for country-level regulatory submissions and site activation. You will collaborate with cross-functional teams to ensure timely and compliant startup activities in a fast-paced CRO setting.

The role requires fluency in English and Turkish, strong communication skills, and the ability to mentor junior staff while navigating local and international regulatory requirements.