Regulatory Affairs Associate (Biologicals & Vaccines)

Job Description
Position: Sr. Associate Regulatory Affairs (Biologicals & Vaccines)
Company: DDReg Pharma Pvt Ltd

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.
Key Responsibilities
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.
Authority Interface & Networking
¢ 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.
Qualifications & Experience
¢ Bachelors or Masters degree in Pharmacy, Life Sciences, Biotechnology, or related field.
¢ 36 years of regulatory affairs experience in biologicals, vaccines, or pharma industry.
¢ Hands-on experience with CDSCO submissions and regulatory pathways is mandatory.

Skills & Competencies
¢ 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.
Location: Gurgaon, India
Mode: Office-Based