Job Overview:
We are looking for a knowledgeable Drug Registration Consultant who has hands-on
experience in handling regulatory approvals and licensing related to pharmaceutical products.
The ideal candidate should be familiar with CDSCO regulations, drug licensing procedures,
and regulatory documentation required for pharmaceutical product approvals in India.
Roles & Responsibilities:
• Handling drug registration and regulatory approvals with CDSCO and State Drug
Authorities.
• Assisting clients in obtaining Drug Licenses (Wholesale, Retail, Manufacturing, and Import
License).
• Preparing and filing applications for drug product approvals and regulatory registrations.
• Coordinating with regulatory authorities for query resolution and application follow-ups.
• Assisting in preparation and submission of technical documentation and regulatory dossiers.
• Ensuring compliance with Drugs and Cosmetics Act, 1940 and related regulatory
guidelines.
• Maintaining proper documentation and regulatory records for client registrations.
• Coordinating with internal teams and clients for required regulatory documentation.
• Monitoring regulatory updates and ensuring compliance with latest CDSCO guidelines.
Required Skills:
• Strong knowledge of CDSCO regulations and drug licensing procedures.
• Understanding of drug registration processes and regulatory compliance.
• Experience in handling drug license applications and approvals.
• Good documentation and regulatory drafting skills.
• Strong attention to detail and compliance management skills.
• Ability to coordinate with regulatory authorities and handle multiple client projects.
Qualifications:
Bachelor’s degree in Pharmacy, Life Sciences, Biotechnology, or related field.
Preferred Experience:
• 1-3 years of experience in drug regulatory affairs or pharmaceutical compliance.
• Experience in handling CDSCO registrations and drug licensing procedures.
• Experience working in pharmaceutical companies, regulatory consulting firms, or
compliance service providers.
• Familiarity with CDSCO portal, SUGAM portal, and regulatory documentation procedures.
Experience
1 - 3 Years
No. of Openings
1
Education
Graduate (B.Pharma)
Role
Regulatory Officer
Industry Type
Pharma / BioTech / Clinical Research
Gender
[ Male / Female ]
Job Country
India
Type of Job
Full Time
Work Location Type
Work from Office
Face interview location
8th Floor, Bhandari House - 91, 804, Nehru Place, New Delhi, Delhi 110019