Regulatory Affairs - CDSCO

Job Position : Regulatory Compliance – Technical Role (CDSCO)
Experience Required : 1 to 3year
Department : Regulatory Affairs / Compliance

Share your CV over [email protected] or DM on WhatsApp 9773660371

Job Description:

• CDSCO Registration for medical devices, Drug & Cosmetics as per the rules and standards.
• Draft, review, submission and archival of other regulatory submissions (Query responses, corrections fillings, miscellaneous notifications regarding post registration regulatory lifecycle management) for Indian market.
• Candidates must know online application filing on Govt. websites.
• Review of technical documents before filing on CDSCO portal.
• Proper knowledge of Medical Device Rules 2017 and other ISO standards for medical device.
• Must know to handle/manage technical queries related to CDSCO (MD, Drug & Cosmetic) registration for client.

Required Skills & Competencies :

• Strong knowledge of Medical Device Rules, 2017 and the Drugs & Cosmetics Act, 1940.
• Experience with regulatory documentation and government portal submissions.
• Excellent client handling and relationship management skills.
• Good presentation and communication abilities.
• Strong understanding of product knowledge and regulatory processes.
• Negotiation and prospecting skills to manage client expectations effectively.

Qualifications:

• Bachelor’s or Master’s degree in Pharmacy, Life Sciences, Biotechnology, or a related discipline.
• Prior experience in regulatory compliance or licensing activities preferred.

Job Type: Full-time

Pay: ₹25,000.00 - ₹45,000.00 per month

Benefits:

• Cell phone reimbursement
• Health insurance
• Life insurance

Application Question(s):

• What is your total experience in CDSCO filings?
• What is your current in-hand salary?
• What is your expected in-hand salary?
• What is your notice period?

Work Location: In person