Sr. Associate / Assistant Manager – (Biologicals & Vaccines) Regulatory Affairs

Location: Gurgaon, India

Work Mode: Office-Based

Experience: 3–6 Years

DDReg Pharma is looking for an experienced Regulatory Affairs professional with expertise in biologicals and vaccines to join our team.

Key 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.

Interested? Join DDReg Pharma and contribute to regulatory excellence in biologicals and vaccines.

Apply now through our careers page or contact us to learn more.

Join DDReg Pharma and contribute to regulatory projects supporting pharmaceutical products across diverse global markets.

Or you can share your CV directly at career@ddreg.in

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