Sr. Associate/Associate – RA_ Biologicals _Vaccines

DDReg Pharma Inc; Gurgaon; On-site; INR 600,000 - 800,000; Full time

Job summary

DDReg Pharma Inc is seeking a Sr. Associate in Regulatory Affairs specializing in Biologicals & Vaccines. This role requires managing regulatory submissions and compliance for biological and biosimilar products in India.

The ideal candidate should possess strong expertise in CDSCO regulations, a degree in Life Sciences or Pharmacy, and 3–6 years of relevant experience in regulatory affairs. The position emphasizes proactive engagement with regulatory authorities and impeccable documentation skills.

Qualifications

• 3–6 years of regulatory affairs experience in biologicals, vaccines, or pharma industry.
• Hands-on experience with CDSCO submissions and regulatory pathways.

Responsibilities

• Prepare, compile, and submit regulatory dossiers for biologicals and vaccines.
• Manage applications for clinical trials, import licenses, and marketing authorizations.
• Respond to CDSCO queries and regulatory communications on time.
• Ensure compliance with New Drugs & Clinical Trial Rules and biologics guidelines.
• Support audit readiness and inspection activities.

Skills

Knowledge of CDSCO regulations

Proficiency in dossier preparation (CTD/eCTD)

Regulatory filings management

Strong networking and liaisoning skills

Excellent analytical and documentation skills

Ability to work in fast-paced environments

Education

Bachelor’s or master’s degree in pharmacy, Life Sciences, Biotechnology

Job description

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.