LikeRemoteSenior Associate Regulatory Submission
from 🇹🇷 Turkey
We are currently seeking aSenior Associate Regulatory Submissions in TĂĽrkiye.
In this role, you will be embedded within ourFunctional Service Provider (FSP) department, working closely with aninternational client in a global, matrix environment.
You will be responsible for the preparation, submission, and maintenance ofclinical trial authorizations, ensuring compliance with local and international regulatory requirements.
Key Responsibilities
- Prepare, submit, and maintainclinical trial applications (CTAs)
- Ensure compliance withlocal 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 theclinical development lifecycle
Education & Experience
- Bachelor’s or advanced degree inLife Sciences, Pharmacy, Medicine, or related field
- Minimum4 years of experience in Regulatory Affairs within pharma or biotech
- Proven experience inclinical trial submissions and authorizations
- Strong understanding ofICH-GCP, GMP, and CTA/IND processes
- Experience working inglobal, matrix organizations
- Ability to manage multiple projects and deadlines
Technical Skills
- Strong knowledge oflocal clinical trial regulations and submission procedures in TĂĽrkiye
- Understanding of thedrug development process and regulatory lifecycle
- Excellent document preparation and review skills
- High attention to detail and regulatory accuracy
#LI-CB1
Learn more about ourEEO & Accommodations request here.
