Senior Associate Regulatory Submission

Company : Fortrea

Job Description - Senior Associate Regulatory Submission

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

#LI-CB1

Learn more about our EEO & Accommodations request here.

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