Regulatory Affairs

2 days ago

Noida Uttar Pradesh, India corpseed ites pvt ltd Full time

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

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

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