We are currently seeking a Senior Associate Regulatory Submissions in Türkiye.
In this role, you will be embedded within our Functional Service Provider (FSP) department, working closely with an international client in a global, matrix environment.
You will be responsible for the preparation, submission, and maintenance of clinical trial authorizations, ensuring compliance with local and international regulatory requirements.
- Prepare, submit, and maintain clinical trial applications (CTAs)
- Ensure compliance with local and global regulatory requirements
- Manage multiple regulatory submissions and projects within tight timelines
- Collaborate with cross-functional and international stakeholders
- Interpret regulatory guidelines and ensure accurate implementation
- Support regulatory activities across the clinical development lifecycle
- Bachelor’s or advanced degree in Life Sciences, Pharmacy, Medicine, or related field
- Minimum 4 years of experience in Regulatory Affairs within pharma or biotech
- Proven experience in clinical trial submissions and authorizations
- Strong understanding of ICH-GCP, GMP, and CTA/IND processes
- Experience working in global, matrix organizations
- Ability to manage multiple projects and deadlines
- Strong knowledge of local clinical trial regulations and submission procedures in Türkiye
- Understanding of the drug development process and regulatory lifecycle
- Excellent document preparation and review skills
- High attention to detail and regulatory accuracy
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Learn more about our EEO & Accommodations request here.
Skills Required
- Bachelor's or advanced degree in Life Sciences, Pharmacy, Medicine, or related field
- Minimum 4 years of experience in Regulatory Affairs within pharma or biotech
- Proven experience in clinical trial submissions and authorizations
- Strong understanding of ICH-GCP, GMP, and CTA/IND processes
- Experience working in global, matrix organizations
- Ability to manage multiple projects and deadlines
- Strong knowledge of local clinical trial regulations and submission procedures in Turkiye
- Excellent document preparation and review skills
- High attention to detail and regulatory accuracy
What We Do
Fortrea (Nasdaq: FTRE) is a leading global provider of clinical development and patient access solutions to the life sciences industry. We partner with emerging and large biopharmaceutical, medical device and diagnostic companies to drive healthcare innovation that accelerates life changing therapies to patients in need. Fortrea provides phase I-IV clinical trial management, clinical pharmacology, differentiated technology-enabled trial solutions and post-approval services. Fortrea’s solutions leverage three decades of experience spanning more than 20 therapeutic areas, a passion for scientific rigor, exceptional insights and a strong investigator site network. Our talented and diverse team working in more than 90 countries is scaled to deliver focused and agile solutions to customers globally. Learn more about how Fortrea is becoming a transformative force from pipeline to patient at Fortrea.com.
