DDReg Pharma is inviting applications for the position of Regulatory Affairs Associate (Biologicals & Vaccines) at its Gurugram, Haryana office. This opportunity is ideal for regulatory affairs professionals with experience in CDSCO submissions, CTD/eCTD dossier preparation, SUGAM portal filings, biologics, biosimilars, and vaccines.

Professionals looking for Regulatory Affairs jobs in Gurugram, CDSCO Regulatory Affairs jobs, Biologicals Regulatory Affairs careers, or Vaccines Regulatory Affairs openings will find this role an excellent opportunity to work with a leading global regulatory consulting company supporting pharmaceutical and biopharmaceutical organizations.

Job Details

About DDReg Pharma

DDReg Pharma is a global regulatory consulting organization providing specialized services across:

• Regulatory Affairs
• Pharmacovigilance
• Quality Assurance
• Intellectual Property Rights (IPR)
• GMP Compliance
• Toxicology

The company supports pharmaceutical, biotechnology, and life sciences organizations through product registration, regulatory strategy, lifecycle management, and compliance. DDReg Pharma also leverages AI-powered Regulatory Intelligence and Regulatory Information Management Systems (RIMS) to streamline regulatory operations.

Regulatory Affairs Associate Responsibilities

The selected candidate will be responsible for:

• Preparing CTD and eCTD regulatory dossiers for biologicals and vaccines.
• Managing CDSCO submissions for biological products.
• Handling clinical trial applications.
• Preparing import license applications.
• Managing test license submissions.
• Supporting marketing authorization applications.
• Performing submissions through the SUGAM portal.
• Managing regulatory variations, amendments, and renewals.
• Responding to CDSCO deficiency letters and regulatory queries.
• Ensuring compliance with NDCTR and biologics guidelines.
• Coordinating documentation with internal teams and clients.
• Monitoring CDSCO notifications and regulatory updates.
• Supporting inspections and audit readiness.
• Liaising with CDSCO officials and regulatory authorities.
• Participating in regulatory meetings and stakeholder discussions.

Required Qualifications

Applicants should possess:

• Bachelor’s or Master’s degree in Pharmacy, Biotechnology, Life Sciences, or related field.
• 3–6 years of Regulatory Affairs experience.
• Strong exposure to biologicals, biosimilars, or vaccines.
• Hands-on experience with CDSCO submissions.
• Experience using the SUGAM portal.
• Practical knowledge of CTD and eCTD dossier preparation.
• Excellent documentation and communication skills.

Preferred Skills

Candidates with the following skills will be preferred:

• Regulatory Affairs
• Biologicals
• Biosimilars
• Vaccines
• CDSCO
• NDCTR
• CTD
• eCTD
• SUGAM Portal
• Import License
• Clinical Trial Applications
• Marketing Authorization
• Regulatory Compliance
• Dossier Compilation
• Regulatory Strategy

Why Join DDReg Pharma?

Working with DDReg Pharma offers several career advantages:

• Opportunity to work on biologicals and vaccine registrations.
• Exposure to CDSCO regulatory pathways.
• Hands-on experience with end-to-end regulatory submissions.
• Opportunity to collaborate with pharmaceutical and biotechnology clients.
• Professional growth in India’s expanding biologics and vaccines sector.
• Exposure to AI-enabled regulatory technologies.
• Stable full-time permanent position in Gurugram.

Salary

Based on current Regulatory Affairs market trends for professionals with 3–6 years of experience in biologicals and vaccines:

Expected Salary: ₹8,50,000 – ₹14,00,000 per annum (CTC)

Actual compensation will depend on candidate experience, technical expertise, and interview performance.

How to Apply

Application Link