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AI Summary
Responsible for the preparation, submission, and maintenance of clinical trial applications (CTAs) in compliance with local and international regulations. The role involves collaborating with international stakeholders to manage regulatory activities across the clinical development lifecycle.
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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