Global clinical research organization Parexel is hiring for Junior Regulatory Affairs Associate and Regulatory Affairs Associate roles for its India (Bengaluru โ Remote) operations. These opportunities are ideal for life sciences graduates and regulatory professionals looking to build or advance their careers in regulatory affairs, clinical trials, and submission management.
Parexel is known for delivering end-to-end clinical development solutions, supporting pharmaceutical and biotech companies in bringing life-saving therapies to market. If you are aiming for a career in drug regulatory affairs, clinical submissions, and global compliance, this is a strong opportunity.
๐น Job Roles Available
1. Junior Regulatory Affairs Associate (0โ2 Years)
Key Responsibilities:
- Assist in regulatory document publishing and formatting
- Perform tasks like bookmarking, hyperlinking, pagination, and submission compilation
- Support regulatory submission package preparation
- Handle document management activities (file transfer, archival, tracking)
- Learn and apply global regulatory submission standards
- Follow SOPs and work instructions
- Support regulatory activities for marketed products
Required Skills:
- Strong attention to detail in documentation
- Ability to work in a team-driven environment
- Basic understanding of regulatory affairs processes
- Good communication and willingness to learn
Qualification:
- Bachelorโs Degree in Life Sciences / Pharmacy / Scientific discipline
2. Regulatory Affairs Associate (2โ4 Years)
Key Responsibilities:
- Manage clinical trial applications (CTA/iCTA) via SUGAM portal
- Handle CTRI registrations and regulatory submissions
- Prepare documents for Subject Expert Committee (SEC) meetings
- Ensure compliance with NDCT Rules and Indian regulatory guidelines
- Coordinate with global sponsors and cross-functional teams
- Track submission timelines and manage query responses
- Maintain submission delivery and content plans
Required Skills:
- Hands-on experience with SUGAM portal & CTRI
- Strong understanding of Indian regulatory framework
- Knowledge of global regulatory harmonization
- Excellent communication and stakeholder management
- Ability to work independently and across time zones
Qualification:
- Bachelorโs/Masterโs in Life Sciences, Pharmacy, or related field
- 2โ4 years of regulatory affairs experience
๐ผ Salary (Expected Range)
- Junior Role: โน3.5 โ โน5.5 LPA
- Associate Role: โน6 โ โน10 LPA
(Salary may vary based on experience and interview performance)
๐ Why Join Parexel?
- Work with a global CRO leader
- Exposure to international regulatory submissions
- Remote work flexibility (Bengaluru-based role)
- Career growth in clinical research & regulatory affairs
- Opportunity to contribute to life-saving therapies
๐ Job Location
- India (Remote โ Bengaluru)
๐ How to Apply
Application Link For Junior Regulatory Affairs Associate (0โ2 Years)
Application Link For Regulatory Affairs Associate (2โ4 Years)
