Sr. Associate/Associate – RA_ Biologicals _Vaccines
Full Time
Gurgaon
Posted 5 days 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)