Parexel Walk-in Interview 2025.Parexel Notification full details below.Interested and eligible candidates can attend Interview on scheduled time and venue.. .
When our values align, there’s no limit to what we can achieve.
At Parexel, we all share the same goal – to improve the world’s health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special – a deep conviction in what we do.
Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we’re committed to making a difference.
Regulatory Affairs Associate & Sr. Regulatory Affairs Associate
locations India-Bengaluru-Remote
India-Hyderabad-Remote
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
