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.
- Robust 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

📌 Sr. Associate/Associate – RA_ Biologicals _Vaccines (Gurugram)
🏢 DDReg Pharma
📍 Gurugram