Back to jobs
Senior Associate Regulatory Submission
IstanbulPosted Yesterday
Full-timeremote
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
#LI-CB1
Learn more about our EEO & Accommodations request here.