Sr. Regulatory Affairs Associate
India, Remote Additional Locations India-Hyderabad-Remote; Job ID R0000032362 Category Consulting Date Posted 03/25/2025Overview
As part of Parexel Consulting, you will play a vital role in helping biopharmaceutical and medical device companies navigate the complex and ever-changing regulatory landscape. Drawing on your scientific, technical, and regulatory expertise, you will work closely with clients to develop and implement regulatory strategies that bring their products to market faster and keep them there.
We value collaboration, innovation, and continuous learning. As a member of our team, you will partner with a diverse group of clients, and be exposed to various product types and therapeutic areas. You will also develop your skills through challenging assignments and mentorship from experienced regulatory professionals. Plus, you will enjoy the flexibility of working remotely while still being part of a supportive and dynamic team.
Success Profile
Do you have these soft skills and interpersonal traits to succeed at Parexel?
- Communicator
- Detail-oriented
- Problem-solver
- Relationship-builder
- Results-driven
- Strategic
About This Role
Regulatory Affairs Associate & Sr. Regulatory Affairs Associate
JOB DESCRIPTION
- Handling Life Cycle Maintenance for approved products including but not limited to filing of CMC variations (for small molecule &/or biological finished formulations), Administrative Variations, Renewals, Marketing Authorization Transfers, Manufacturing Site Transfers, Site Name Change variations and Safety &/or labeling changes in varied markets including but not limied to Euprope, ASEAN and Other Regulated markets
- Review of dossiers for EU in eCTD format and International markets.
- Handling Health Authority Queries within predefined time with adequacy and accuracy, Change Control management
- Independently communicate and coordinate with various stakeholders (internal & external) to ensure timely submission of regulatory applications
- Identify gaps in existing business (regulatory) processes and trainings to perform the required tasks and input process improvements to achieve process excellence.
ELIGIBILITY CRITERIA
- Candidates with 3 to 8 years of experience in handling submissions in varied markets. Experience in handling EU submissions would be preferred.
- Candidates with experience/ in-depth knowledge in handling post approval changes EU markets
- Candidates with working experience in handling RIMS tools. Hands on experience in Veeva Vault tool would be preferred
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