[Hiring] Senior Associate Regulatory Submission @Fortrea

Role 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.

• 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

Qualifications

• 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

Requirements

• 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

Company Description