Fortrea

Senior Associate Regulatory Submission

Fortrea  •  Istanbul, TR (Onsite)  •  3 hours ago
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Job Description

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.

Key Responsibilities

  • 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

Education & Experience

  • 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

Technical Skills

  • 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

Fortrea

About Fortrea

Fortrea (Nasdaq: FTRE) is a leading global clinical research organization (CRO) dedicated to providing innovative clinical development solutions to the life sciences industry. With over 30 years of clinical research experience, Fortrea has evolved from Covance and Labcorp into a pureplay CRO built for biotech, biopharma, medical device and diagnostic innovators.

Fortrea collaborates with both emerging and established companies to deliver agile, fit-for-purpose full service (FSO), functional service (FSP) and hybrid solutions. Fortrea provides comprehensive Phase I-IV clinical trial management, clinical pharmacology, and consulting services, backed by deep experience in more than 20 therapeutic areas.

Operating in approximately 100 countries, our diverse and talented team brings scientific rigor, operational excellence, and a strong investigator site network to every trial. By combining the best of our legacy experience with forward-thinking innovation, Fortrea brings predictability to clinical trial execution and helps transform aspirations into outcomes.

Together, exceptional is possible.

Learn more at Fortrea.com

Industry
Biotech & Life Sciences
Company Size
10,000+ employees
Headquarters
Research Triangle Park, NC
Year Founded
Unknown
Website
fortrea.com
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