Are you an experienced Regulatory Affairs – CMC professional looking to grow your career with a globally recognized CRO? Here’s your chance to join Parexel and contribute to life-changing therapies that impact patients worldwide 💊✨
📍 Location Options:
- Bengaluru
- Hyderabad (Remote)
- Bengaluru (Remote)
🕒 Job Type: Full-Time
🌍 Shift: EU Shift
If you are passionate about global compliance, regulatory excellence, and improving global health, this could be your next big career move 🚀
🏢 About Parexel
Parexel is a leading global Clinical Research Organization (CRO) offering services in clinical trials, regulatory consulting, and market access. The company partners with pharmaceutical, biotech, and medical device organizations to accelerate the delivery of safe and effective therapies to patients.
Their work culture is built around empathy, accountability, collaboration, and meaningful global impact 🌱
💼 Job Role: Regulatory Affairs Associate (CMC Focus)
This position primarily supports Regulatory Affairs – Chemistry, Manufacturing, and Controls (CMC) activities with a focus on EU regulatory frameworks.
You’ll be working closely with cross-functional global teams to ensure accurate submissions and lifecycle compliance across EU markets.
📌 Key Responsibilities
As a Regulatory Affairs Associate, you will:
✅ Understand global regulatory frameworks for small & large molecules
✅ Provide regulatory input on CMC documentation
✅ Support submission delivery strategies
✅ Review regulatory documents for compliance and accuracy
✅ Analyze EU regulatory procedures and special designations
✅ Author/update dossier sections related to MAA (Marketing Authorization Application)
✅ Evaluate post-approval regulatory changes per country guidelines
✅ Manage EU product lifecycle activities
✅ Submit and review regulatory dossiers
✅ Communicate with EU Health Authorities (HA)
✅ Collaborate with Medical, Marketing, and Market Access teams
This role requires strong technical knowledge along with stakeholder coordination skills 🤝
🎯 Required Experience & Skills
✔ Experience in Regulatory Affairs – CMC
✔ Understanding of EU regulatory procedures
✔ Knowledge of lifecycle management & post-approval changes
✔ Experience in dossier preparation & submission
✔ Familiarity with MAA updates
✔ Comfortable working in EU shifts
✔ Strong communication & coordination skills
Experience handling EU market regulatory activities is a strong advantage 🌍
🌟 Why Consider This Role?
✨ Work with a globally reputed CRO
✨ Exposure to EU Health Authority interactions
✨ Remote flexibility (role/location dependent)
✨ Opportunity to work on innovative therapies
✨ Clear growth path in regulatory science
📈 Career Growth in Regulatory Affairs
Regulatory Affairs professionals with EU CMC expertise are in high demand globally. With increasing regulatory complexity, this experience can lead to advanced roles such as:
- Senior Regulatory Affairs Associate
- Regulatory Affairs Manager
- Global Regulatory Strategy Lead
- CMC Regulatory Specialist
Strong EU regulatory exposure significantly boosts international career prospects 🌎
