Location: Gurgaon, India
Work Mode: Office-Based
Experience: 3 6 Years
DDReg Pharma is looking for an experienced Regulatory Affairs skilled with expertise in biologicals and vaccines to join our team.
Responsibilities
- Prepare and submit CTD/eCTD regulatory dossiers to CDSCO.
- Manage clinical trial applications, licenses, marketing authorizations, variations, and renewals.
- Handle SUGAM portal submissions and regulatory queries.
- Ensure compliance with applicable CDSCO regulations, NDCTR, and biologics guidelines.
- Coordinate with clients, internal teams, and regulatory authorities.
Requirements
- Bachelor's or Master's degree in Pharmacy, Life Sciences, Biotechnology, or a related field.
- 3 6 years of relevant regulatory affairs experience.
- Hands-on experience with CDSCO submissions, CTD/eCTD dossiers, and the SUGAM portal.
- Strong regulatory documentation, communication, and stakeholder management skills.
Disclaimer: This job posting has been aggregated from external source. Role details, content, and availability are subject to change. Applicants are advised to confirm the latest information directly on the company website before applying.