Executive Sr.Executive - RA Leading Pharma (OSD) - Puducherry

Role & responsibilities

. Key Responsibilities

1. Prepare, compile, review, and submit applications and supporting documents to the State Drug Control Department, CDSCO, and other applicable regulatory authorities.
2. Handle applications related to:
• Manufacturing Drug Licences
• Product permission/approvals
• Licence renewals
• Licence amendments
• Addition/deletion of products
• Change in manufacturing premises
• Change in technical staff / competent persons
• Loan licence/contract manufacturing requirements
• Export-related regulatory documentation
• Other statutory licences and permissions as applicable.
3. Coordinate with Quality Assurance, Quality Control, Production, Engineering, R&D, Warehouse, and other departments for collection and compilation of documents required for regulatory submissions.
4. Ensure that regulatory submissions are complete, accurate, and compliant with applicable Drugs & Cosmetics Act, Rules, Schedule M, CDSCO requirements, and applicable State Drug Control requirements.
5. Track the status of applications, licences, permissions, approvals, queries, deficiencies, and regulatory commitments.
6. Prepare appropriate responses to queries, observations, deficiency letters, and inspection-related communications received from regulatory authorities.
7. Coordinate with regulatory authorities and facilitate Drug Inspector / CDSCO inspections whenever required.
8. Maintain an updated database/register of:
• Drug licences
• Product permissions
• Regulatory approvals
• Licence validity
• Renewals
• Amendments
• Regulatory submissions and correspondence.
9. Ensure timely renewal and amendment of applicable licences and regulatory approvals to avoid expiry or non-compliance.
10. Review regulatory requirements for new products, new dosage forms, manufacturing changes, and facility modifications and advise the concerned departments regarding documentation requirements.
11. Maintain proper records of all regulatory submissions, approvals, correspondence, and supporting documents for inspection and audit purposes.
12. Monitor applicable changes in regulatory requirements and communicate relevant updates to management and concerned departments.
13. Support preparation of documents required for export NOCs, COPP, FSC, GMP certificates, WHO-GMP and other regulatory/export certifications, wherever applicable.
14. Ensure confidentiality, accuracy, traceability, and proper document control of all regulatory records.

Preferred candidate profile

Experience

• 810 years of experience in Regulatory Affairs / Drug Regulatory Compliance in a pharmaceutical manufacturing organization.
• Experience in handling ONDLS & Sugam portal of drug licence applications, amendments, renewals, product permissions, CDSCO/State Drug Control submissions, and regulatory inspections will be preferred.

Required Knowledge

The candidate should have working knowledge of:

• Drugs & Cosmetics Act and Rules
• CDSCO regulatory requirements
• State Drug Control requirements
• GMP / Schedule M requirements
• Pharmaceutical manufacturing licence requirements
• Product permission / approval requirements
• Regulatory documentation and dossier preparation
• Regulatory inspection requirements
• Documentation and record management