Parexel is hiring a Regulatory Affairs Associate (Clinical Trial Application) for a remote India-based role. This is a strong opportunity for professionals with 2โ4 years of regulatory affairs experience, especially those skilled in SUGAM portal submissions, NDCT Rules, and clinical trial approvals in India.
Parexel, a global CRO, plays a critical role in accelerating drug development and improving patient outcomes. This role is ideal for candidates aiming to build expertise in clinical trial regulatory submissions, global regulatory harmonization, and Indian health authority processes.
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Key Responsibilities
- Prepare and submit Clinical Trial Applications (CTA/iCTA) via the SUGAM portal
- Manage regulatory submissions, amendments, and query responses within timelines
- Coordinate with global sponsors and cross-functional teams
- Support documentation for Subject Expert Committee (SEC) meetings
- Handle Clinical Trials Registry of India (CTRI) registrations
- Track regulatory updates, NDCT Rules, and Gazette notifications
- Maintain submission delivery plans and status updates
- Ensure compliance with Indian regulatory guidelines and global standards
- Mentor junior team members and support internal stakeholders
Required Qualifications
- Bachelorโs or Masterโs in Pharmacy, Life Sciences, or related field
- 2โ4 years of experience in Regulatory Affairs (Clinical Trials)
- Strong knowledge of:
- NDCT Rules (India)
- SUGAM portal submissions
- CTRI registration process
- Experience with global regulatory frameworks and harmonization
- Excellent communication and stakeholder management skills
- Ability to work independently and across time zones
Preferred Skills
- Hands-on experience with clinical trial regulatory documentation
- Familiarity with health authority interactions in India
- Strong project management and timeline tracking ability
Salary & Benefits
- Estimated Salary: โน5 LPA โ โน10 LPA (based on experience)
- Fully remote work flexibility (India)
- Exposure to global clinical trials and regulatory processes
- Opportunity to work with a leading CRO (Contract Research Organization)
- Career growth in clinical regulatory affairs and drug development
How to Apply
