Regulatory Affairs Associate – Parexel (Remote India)

Parexel, a global leader in clinical research and regulatory consulting, is hiring a Senior Regulatory Affairs Associate for remote positions in India (Bengaluru & Hyderabad). This role offers an excellent opportunity to work on global regulatory submissions across the US, EU, Japan, Canada, Switzerland, and Australia, supporting innovative biologics, vaccines, monoclonal antibodies, and small molecules.

At Parexel, regulatory professionals play a direct role in improving patient lives by enabling timely approvals of life-changing therapies. If you have strong expertise in regulatory lifecycle management and CMC regulatory affairs, this role is well aligned with your career growth.

Key Responsibilities – Senior Regulatory Affairs Associate

• Handle new registrations, renewals, and lifecycle management activities for:
  • Biologicals
  • Vaccines
  • Recombinant proteins
  • Monoclonal antibodies
  • Plasma-derived products
  • Small molecules
• Contribute to authoring, preparation, and delivery of regulatory submissions from global and regional perspectives.
• Prepare and review Marketing Authorization Applications (MAA) and post-approval variations.
• Support regulatory filings across US FDA, EMA, PMDA (Japan), Health Canada, Swissmedic, and TGA Australia.
• Apply in-depth knowledge of ICH guidelines, global pharmaceutical legislation, and CMC regulatory requirements.
• Collaborate cross-functionally with internal stakeholders while working independently in a remote environment.

Qualifications & Skills Required

• Degree in Pharmacy, Life Sciences, Biotechnology, or related discipline.
• Strong experience in Regulatory Affairs for global markets (US, EU, Japan, Canada, Australia).
• Proven expertise in CMC regulatory submissions for biologics and small molecules.
• Hands-on experience with MAA, variations, renewals, and lifecycle management.
• Excellent written and verbal communication skills.
• Ability to manage multiple submissions independently in a fast-paced environment.

Why Join Parexel?

• 🌍 Global exposure to major regulatory agencies
• 🏠 Permanent remote work (India-based)
• 📈 Strong career growth in Regulatory Affairs & CMC
• 💼 Work with a top global CRO trusted by leading pharma companies
• 🤝 Collaborative, patient-focused work culture

Salary Information (Estimated)

• INR 12,00,000 – 18,00,000 per annum
  (Salary may vary based on experience, regulatory expertise, and location.)

How to Apply

Application Link