Parexel, a global leader in Contract Research Organization (CRO) services, is hiring for the role of Regulatory Affairs Associate.
This is a remote (work-from-home) opportunity for professionals with 2–4 years of Regulatory Affairs experience, especially in CMC and global submissions.
Job Overview
| Particular | Details |
|---|---|
| Company | Parexel |
| Position | Regulatory Affairs Associate |
| Experience | 2–4 Years |
| Qualification | Pharmacy / Life Sciences / Biotechnology |
| Work Mode | Remote |
| Location (Hiring Base) | Bengaluru, India |
| Industry | CRO / Pharmaceutical |
| Job Type | Full-Time |
Key Responsibilities
- Interpret global regulatory frameworks
- Support Annual Reports & Renewals submissions
- Work on regulatory activities for US, EU, LATAM, Brazil, China
- Collaborate with CMC, Clinical, QA & Regulatory teams
- Evaluate regulatory changes as per country guidelines
- Handle lifecycle management of products
- Ensure compliance with CTD / eCTD guidelines
- Contribute to regulatory documentation strategy
Required Qualifications
- Bachelor’s Degree in:
- Pharmacy
- Life Sciences
- Biotechnology
- Pharmaceutical Sciences
- OR any graduate with relevant RA experience
Experience Required
- ✔ 2–4 years in Regulatory Affairs (CMC)
- ✔ Experience in annual reports & renewals
- ✔ Exposure to global markets preferred
Required Skills
- Regulatory Affairs – CMC
- CTD / eCTD submissions
- ICH Guidelines
- USFDA & EU Regulations
- Lifecycle Management
- Regulatory Documentation
- Change Control & Compliance
- Pharmacovigilance basics
Preferred Experience
- EU lifecycle management
- US/EU Annual Reports
- LATAM, Brazil & China submissions
- Cross-functional collaboration
Benefits of Working at Parexel
- 🏠 Remote / Work From Home flexibility
- 🌍 Global exposure (US, EU, LATAM markets)
- 📈 Strong career growth in CRO industry
- 🤝 Collaborative global teams
- 💡 Work on innovative healthcare projects
Job Location
- Remote (India)
- Hiring base: Bengaluru
How to Apply
Apply online through the official careers page:
Why Join Parexel?
- One of the world’s leading CROs
- Work on global regulatory submissions
- Opportunity to grow in high-demand RA domain
- Exposure to multiple regulatory authorities
Job Highlights
- ✅ Remote pharma job
- ✅ 2–4 years experience required
- ✅ Global regulatory exposure
- ✅ CRO industry opportunity
- ✅ High career growth role
FAQs
1. Is this a remote job?
Yes, this is a work-from-home opportunity.
2. What experience is required?
2–4 years in Regulatory Affairs (CMC).
3. Who can apply?
Candidates with Pharmacy or Life Sciences background.
4. Is global exposure required?
Preferred, but not mandatory.
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