Job Description – Licensing & Regulatory Affairs Executive

Company Name: Nyasa Biomed Pvt. Ltd.

Location: Satara

Educational Qualification

- B.Pharm / M.Pharm from a recognized university.

Experience Required

- 5–7 years of experience in Regulatory Affairs and Licensing in a pharmaceutical manufacturing company.

- Experience in handling product registrations, regulatory documentation, and licensing activities.

Key Responsibilities

- Prepare, review, and maintain regulatory documents, dossiers, and submissions.

- Manage product registration processes and ensure timely submission of regulatory requirements.

- Apply for, obtain, and renew manufacturing licenses, product licenses, and other statutory approvals.

- Ensure compliance with:

o Drugs & Cosmetics Act & Rules

o CDSCO guidelines

o State FDA regulations

- Coordinate with State FDA, CDSCO, and other regulatory authorities for approvals, queries, and compliance requirements.

- Prepare and submit documents for product registrations, permissions, amendments, and regulatory approvals.

- Maintain regulatory records, licenses, certificates, approvals, and official correspondence.

- Coordinate with QA, QC, Production, Product Development,



and Marketing departments for regulatory support.

- Monitor regulatory updates and ensure timely implementation of revised requirements.

- Respond to regulatory queries and provide necessary supporting documentation.

- Support internal and external regulatory audits and inspections.

- Ensure timely renewal of licenses, certificates, and regulatory approvals.

- Prepare periodic MIS reports related to regulatory and licensing activities.

- Perform other regulatory and compliance-related responsibilities assigned by management.

Required Skills & Competencies

- Strong knowledge of pharmaceutical laws and regulatory guidelines.

- Good understanding of Drugs & Cosmetics Act, CDSCO, State FDA regulations, and licensing procedures.

- Experience in preparation and submission of regulatory dossiers.

- Solid technical writing and documentation skills.

- Excellent communication and coordination skills.

- Ability to manage regulatory timelines and follow up with authorities.

Pay: ₹12,000.00 - ₹25,000.00 per month

Benefits:

- Paid time off
- Provident Fund

Work Location: In person

📌 Licensing & Regulatory Affairs Executive (India)
🏢 NYSA BIOMED PRIVATE
📍 India