Full Time
Gurgaon
Posted 1 day ago
Position: Sr. Associate – Regulatory Affairs (Biologicals & Vaccines)
Role Summary:
The Sr. Associate – Regulatory Affairs (Biologicals & Vaccines) at DDReg Pharma Pvt Ltd will be responsible for managing regulatory submissions, approvals, and compliance for biological/biosimilar products and vaccines in India. The role requires strong expertise in CDSCO regulations, end-to-end dossier handling, and proactive engagement with regulatory authorities.
Job Descriptions
Prepare, compile, and submit regulatory dossiers (CTD/eCTD) for biologicals and vaccines to CDSCO.
Manage applications for clinical trials, import licenses, test licenses, and marketing authorizations.
Handle filings via SUGAM portal including new submissions, variations, amendments, and renewals.
Respond to CDSCO queries, deficiencies, and regulatory communications professionally and on time.
Ensure compliance with applicable guidelines including New Drugs & Clinical Trial Rules (NDCTR) and biologics guidelines.
Coordinate with internal and client teams for documentation, data requirements, and regulatory strategy.
Maintain up-to-date knowledge of regulatory changes, circulars, and notifications from CDSCO.
Support audit readiness and inspection activities.
Knowledge, Skills and Abilities
Strong knowledge of CDSCO regulations, NDCTR, and biologics regulatory pathways.
Proficiency in dossier preparation (CTD/eCTD) and SUGAM portal submissions.
Demonstrated ability to handle regulatory filings independently.
Strong networking and liaisoning skills with CDSCO authorities.
Excellent analytical, documentation, and communication skills.
Ability to work in a fast-paced consulting environment with multiple projects.
Act as key liaison with CDSCO officials, subject experts, and regulatory consultants.
Establish and maintain effective professional relationships with regulatory authorities.
Represent DDReg Pharma in regulatory meetings and discussions with CDSCO.
Coordinate with industry forums and stakeholders when required.
Qualification and Experience
Bachelor’s or master’s degree in pharmacy, Life Sciences, Biotechnology, or related field.
3–6 years of regulatory affairs experience in biologicals, vaccines, or pharma industry.
Hands-on experience with CDSCO submissions and regulatory pathways is mandatory.
Location
Gurgaon, Haryana (INDIA)
Related
Job Features
Job Category
Regulatory Affairs
