Parexel is a leading global clinical research organization (CRO) dedicated to improving patient health through innovative drug development solutions. With expertise in regulatory affairs, clinical trials, and market access, Parexel supports biopharma companies in bringing life-changing therapies to market.
Job Description: Regulatory Affairs Associate & Sr. Regulatory Affairs Associate
Key Responsibilities:
✔ Regulatory Submissions: Handle lifecycle maintenance for approved products, including CMC variations, renewals, and marketing authorization transfers for EU, ASEAN, and other regulated markets.
✔ Dossier Review: Assess EU eCTD dossiers and international submissions for compliance.
✔ Health Authority Queries: Respond to regulatory agency questions with accuracy and within deadlines.
✔ Stakeholder Coordination: Work with cross-functional teams (internal & external) to ensure timely submissions.
✔ Process Improvement: Identify gaps in regulatory workflows and suggest enhancements.
Eligibility Criteria
✅ Experience: 3-8 years in regulatory affairs, preferably with EU submissions.
✅ Skills:
- Expertise in post-approval changes (EU markets).
- Familiarity with RIMS tools (Veeva Vault preferred).
- Strong knowledge of small molecules & biologics.
✅ Education: Degree in Pharmacy, Life Sciences, or related field.
Why Join Parexel?
💼 Global Impact: Contribute to life-saving therapies reaching patients faster.
🌍 Remote Flexibility: Work from Bengaluru or Hyderabad (Remote).
📈 Career Growth: Opportunities in regulatory strategy, consulting, and leadership.
🩺 Patient-Centric Culture: Be part of a mission-driven team.
How to Apply
📌 Job ID: R0000032362
📍 Locations: Remote (India – Bengaluru/Hyderabad)
