Freyr is currently hiring professionals for the Clinical Trial Submissions (CTS) Operations role in Hyderabad, India. This opportunity is ideal for candidates with 3-5 years of experience in regulatory submissions, EU/UK clinical trial regulations, and ICH-GCP guidelines.
The role focuses on clinical trial regulatory submission operations, submission package preparation, EDMS management, and coordination with global regulatory stakeholders. Professionals experienced in CTIS, IRAS portals, and clinical trial authorization submissions will have a competitive advantage.
This is a strong opportunity for candidates seeking Clinical Research, Regulatory Affairs, and Clinical Trial Submission jobs in India.
Job Overview
| Parameter | Details |
|---|---|
| Company | Freyr |
| Position | Clinical Trial Submissions (CTS) Operations |
| Experience | 3 โ 5 Years |
| Job Location | Hyderabad, India |
| Employment Type | Full Time |
| Industry | Analytics / KPO / Research |
| Department | Customer Success / Service / Operations |
Key Responsibilities
The selected candidate will support clinical trial regulatory submission operations across EU and UK regions.
Primary responsibilities include:
- Preparing and dispatching clinical trial submission packages
- Performing quality review of regulatory submission documents
- Supporting clinical trial authorization submissions
- Managing submission archival activities
- Using Electronic Document Management Systems (EDMS)
- Coordinating with cross-functional regulatory teams
- Maintaining process documentation, job aids, and work instructions
- Formatting regulatory documents across Word, PDF, Excel, and PowerPoint
- Managing submission tracking and project communications
- Supporting regulatory system activities such as User Acceptance Testing (UAT)
Required Qualifications
Candidates applying for this Clinical Trial Submissions Operations job should meet the following criteria:
Education
- Bachelorโs Degree or Postgraduate Degree in Life Sciences, Pharmacy, Biotechnology, or related fields
Experience
- 3โ5 years experience in regulatory submission operations
Technical Knowledge
- EU and UK Clinical Trial Regulations
- ICH-GCP guidelines
- Regulatory submission lifecycle
- Experience with EDMS systems
- Clinical trial documentation management
Preferred Skills
The following skills will strengthen your application:
- Experience with CTIS portal
- Experience with IRAS regulatory portal
- Understanding of Clinical Trial Authorization (CTA) submissions
- Experience in User Acceptance Testing (UAT) for regulatory systems
- Knowledge of Power BI or data visualization tools
- Strong document formatting and regulatory documentation skills
Workplace Skills Required
Freyr expects candidates to demonstrate:
- Strong written and verbal communication skills
- Ability to collaborate with international regulatory stakeholders
- Excellent organizational and documentation skills
- Strong attention to detail
- Critical thinking and problem-solving abilities
- Ability to work in fast-paced global environments
Estimated Salary
Based on industry standards for Clinical Trial Submissions professionals in India:
โน8,00,000 โ โน14,00,000 per year (Estimated Range)
Actual compensation may vary depending on experience, technical skills, and regulatory expertise.
Why Consider This Role?
This Clinical Trial Submissions job in Hyderabad offers the opportunity to work with global regulatory teams and contribute to the full lifecycle of clinical trial submissions in EU and UK markets.
Benefits may include:
- Exposure to global clinical regulatory processes
- Work with international clinical trial teams
- Experience with advanced regulatory systems and portals
- Career growth in clinical research and regulatory affairs
How to Apply
