DDReg Pharma Wanted Senior Associate, Assistant Manager – Regulatory Affairs (biologicals and vaccines)

DDReg Pharma Recruitment – Regulatory Affairs (Biologicals & Vaccines)

DDReg Pharma is hiring for the Senior Associate / Assistant Manager – Regulatory Affairs (Biologicals & Vaccines) position in Gurgaon, India. This opportunity is suitable for regulatory affairs professionals with 3–6 years of relevant experience in pharmaceutical regulatory submissions. The role focuses on preparing CTD/eCTD dossiers, managing CDSCO submissions, handling SUGAM portal activities, and supporting regulatory approvals for biological products and vaccines. Candidates with qualifications in Pharmacy, Life Sciences, Biotechnology, or related disciplines and hands-on regulatory submission experience can apply.

Company Overview

DDReg Pharma provides regulatory and pharmaceutical consulting services supporting regulatory projects across global markets. This position focuses on regulatory affairs activities related to biological products and vaccines, including dossier preparation, submission management, and regulatory compliance.

Job Details

Job Role & Responsibilities

The selected candidate will support regulatory submissions and compliance activities for biological products and vaccines in accordance with applicable Indian regulatory requirements.

Key responsibilities include:

• Prepare and submit Common Technical Document (CTD) and electronic Common Technical Document (eCTD) regulatory dossiers to the Central Drugs Standard Control Organisation (CDSCO).

• Manage clinical trial applications, licences, marketing authorisations, variations, and renewals.

• Handle submissions through the SUGAM portal and respond to regulatory queries.

• Ensure compliance with applicable CDSCO regulations, New Drugs and Clinical Trials Rules (NDCTR), and biologics guidelines.

• Coordinate regulatory activities with clients, internal teams, and regulatory authorities.

• Support documentation and submission processes to facilitate regulatory review and approvals.

Eligibility & Qualifications

Candidates should have a bachelor’s or master’s degree in Pharmacy, Life Sciences, Biotechnology, or a related field.

Relevant qualifications include B.Pharm, M.Pharm, Pharm.D, B.Sc. Life Sciences, M.Sc. Life Sciences, B.Sc. Biotechnology, M.Sc. Biotechnology, or related scientific qualifications aligned with the employer’s stated requirements.

Experience Requirements

• 3–6 years of relevant Regulatory Affairs experience.

• Hands-on experience with CDSCO regulatory submissions.

• Practical experience preparing CTD/eCTD dossiers.

• Experience using the SUGAM portal for regulatory submissions.

• Understanding of applicable regulatory requirements for biological products and vaccines.

Required Skills

• Regulatory documentation and dossier preparation.

• Knowledge of CDSCO submission procedures and regulatory requirements.

• Familiarity with NDCTR and applicable biologics guidelines.

• Strong written and verbal communication skills.

• Stakeholder coordination and client communication.

• Ability to manage regulatory submissions and related documentation accurately.

Job Location & Work Environment

The position is based in Gurgaon, Haryana, and follows an office-based working arrangement. The role involves coordination with clients, internal departments, and regulatory authorities to support biologicals and vaccine regulatory projects.

How to Apply

Interested candidates can apply through the DDReg Pharma careers page or submit their CV directly by email.

• Careers page: Senior Associate / Assistant Manager – Regulatory Affairs

• Email: career@ddreg.in

• Company website: DDReg Pharma

Candidates should highlight their CDSCO submission experience, CTD/eCTD dossier preparation, and SUGAM portal expertise in their applications.

Job Summary