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Regulatory Manager

Çankaya, Turkey

Job Title: Regulatory Manager – Clinical Trials

Location: (Preferably) Ankara/Istanbul Turkey (Hybrid/On-site)

Company: Medex CRO

Industry: Clinical Research

Job Type: Full-Time

What You’ll Do: (Responsibilities)

Lead regulatory submission processes for clinical trials (Phase I–IV) in accordance with local and international regulatory requirements (MoH, EC, EMA, ICH-GCP)

Manage and oversee preparation, submission, and follow-up of Clinical Trial Applications (CTA), amendments, safety reports, and other regulatory documents.

Serve as the primary regulatory liaison with Turkish Ministry of Health (TITCK), Ethics Committees, and other relevant regulatory authorities.

Provide strategic regulatory guidance to project teams, sponsors, and investigators throughout the trial lifecycle.

Maintain up-to-date knowledge of regulatory requirements and ensure internal SOPs and practices remain compliant

Coordinate with internal cross-functional teams (clinical, data management, QA, etc.) and external stakeholders (sponsors, partners).

Train and mentor junior regulatory staff.

The Regulatory Manager ensures that clinical trials (Phase I–IV) are conducted in compliance with local and international regulations. They manage communication with authorities such as the MoH and Ethics Committees, oversee submissions and safety reports, provide strategic regulatory guidance to project teams, ensure internal compliance, and support the development of the regulatory team.

Regulatory Manager – Job Description

Nice to Have

- Prior experience with multinational clinical trials across EMEA
- Familiarity with regulatory intelligence tools and databases
- Experience in direct client communication and relationship management

Must Have

- Bachelor’s or Master’s degree in Life Sciences, Pharmacy, Medicine, or relevant experience in the field,
- Minimum of 5 years of experience in regulatory affairs, preferably within a CRO or pharmaceutical company setting.
- In-depth knowledge of Turkish clinical trial regulations, GCP, and international regulatory frameworks (EMA, FDA, ICH).
- Strong experience with regulatory submissions, MoH processes, and Ethics Committee interactions in Turkey.
- Excellent communication and interpersonal skills in both Turkish and English.
- Strong leadership and project management abilities.