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.
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.
- Strong 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
