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

Linuxlaboratories; Puducherry, Chennai; On-site; INR 600,000 - 1,200,000; Full time

Job summary

Linuxlaboratories in Puducherry, India seeks an experienced Regulatory Affairs professional to manage regulatory submissions and license renewals. You will coordinate with QA, Production, and R&D to compile documents for CDSCO and State Drug Control authorities, track approvals, and handle inspections.

The role requires strong knowledge of the Drugs & Cosmetics Act, regulatory documentation, and dossier preparation to ensure compliance across all regulatory activities.

Qualifications

• Experience in regulatory filings with CDSCO/State Drug Control authorities.
• Strong knowledge of Drugs & Cosmetics Act and Rules.
• Experience in dossier compilation and regulatory submissions.

Responsibilities

• Prepare, compile, and submit applications to regulatory authorities (CDSCO, State Drug Control).
• Coordinate with QA, QC, Production, Engineering, R&D, and other departments for document collection.
• Track status of licenses, approvals, and regulatory queries; respond to observations and deficiency letters.
• Coordinate with regulators for Drug Inspector / CDSCO inspections.
• Maintain updated records of licenses, approvals, renewals, amendments, and submissions.
• Ensure timely renewals and compliance for all regulatory licenses.

Skills

Regulatory affairs

Documentation

CDSCO knowledge

GMP knowledge

Education

Bachelor's in Pharmacy

Job description

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.

• Coordinate with Quality Assurance, Quality Control, Production, Engineering, R&D, Warehouse, and other departments for collection and compilation of documents required for regulatory submissions.
• 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.
• Track the status of applications, licences, permissions, approvals, queries, deficiencies, and regulatory commitments.
• Prepare appropriate responses to queries, observations, deficiency letters, and inspection-related communications received from regulatory authorities.
• Coordinate with regulatory authorities and facilitate Drug Inspector / CDSCO inspections whenever required.
• Maintain an updated database/register of:
• Drug licences
• Product permissions
• Regulatory approvals
• Licence validity
• Renewals
• Amendments
• Regulatory submissions and correspondence.
• Ensure timely renewal and amendment of applicable licences and regulatory approvals to avoid expiry or non-compliance.
• Review regulatory requirements for new products, new dosage forms, manufacturing changes, and facility modifications and advise the concerned departments regarding documentation requirements.
• Maintain proper records of all regulatory submissions, approvals, correspondence, and supporting documents for inspection and audit purposes.
• Monitor applicable changes in regulatory requirements and communicate relevant updates to management and concerned departments.
• Support preparation of documents required for export NOCs, COPP, FSC, GMP certificates, WHO-GMP and other regulatory/export certifications, wherever applicable.
• 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