Global CRO leader Parexel is hiring a Regulatory Affairs Associate (CMC) for India (Bengaluru/Hyderabad – Onsite & Remote options). This is an excellent opportunity for professionals with Regulatory Affairs-CMC experience looking to work on EU regulatory submissions, MAA lifecycle management, and dossier authoring.
If you have experience in EU regulatory affairs, CMC documentation, submission strategy, and health authority interactions, this role offers strong global exposure and structured growth within a leading clinical research organization.
🔬 Key Responsibilities – Regulatory Affairs Associate (CMC)
As a Regulatory Affairs Associate at Parexel, your responsibilities will include:
- Understanding the global regulatory framework, including EU trends for small and large molecules
- Providing regulatory input on CMC documentation requirements
- Supporting submission delivery strategy and regulatory planning
- Reviewing and analyzing regulatory procedures and special designations
- Developing and maintaining submission delivery plans
- Authoring and updating dossier sections based on changes to approved MAA (Marketing Authorization Application)
- Managing EU lifecycle activities and post-approval changes
- Reviewing and submitting dossiers to Health Authorities
- Negotiating and responding to Health Authority queries
- Coordinating with cross-functional teams (Regulatory, Medical, Marketing, Market Access)
- Working in EU shifts
This role demands strong expertise in regulatory submissions, change evaluation, and EU regulatory guidelines.
🎓 Qualifications & Experience
Required:
- Relevant experience in Regulatory Affairs – CMC
- Knowledge of EU regulatory procedures
- Experience with MAA lifecycle management
- Understanding of change evaluation as per country guidelines
- Strong documentation and dossier review skills
- Willingness to work in EU shifts
Preferred:
- Experience handling EU market lifecycle activities
- Health Authority interaction experience
Educational qualifications typically include:
- M.Pharm / B.Pharm
- MSc (Life Sciences / Chemistry / Biotechnology)
- Related regulatory sciences background
🌍 Why Join Parexel?
At Parexel, employees contribute directly to improving global health outcomes. Benefits include:
- Exposure to global regulatory frameworks
- Work on EU submissions and lifecycle projects
- Remote work flexibility
- Career growth in Regulatory Affairs CMC
- Collaborative cross-functional environment
Parexel is known for structured regulatory processes, international exposure, and a patient-focused culture.
💰 Salary Details (Estimated)
Based on industry standards for Regulatory Affairs Associate – CMC in India:
- ₹6,00,000 – ₹12,00,000 per annum (Depending on experience and expertise)
📍 Job Location
- India – Bengaluru
- India – Hyderabad (Remote option available)
- Bengaluru (Remote option available)
📌 How to Apply
