Sr. Assoc / Asst Manager (Biologicals & Vaccines) Regulatory Affairs

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.

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