Executive Sr.executive - Ra Leading Pharma (osd) - Puducherry
Description:
Role & responsibilities
. Key Responsibilities
Prepare, compile, review, and submit applications and supporting documents to the State Drug Control Department, CDSCO, and other applicable regulatory authorities.
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
Job Classification
Industry: Pharmaceutical & Life Sciences
Functional Area / Department: Legal & Regulatory
Role Category: Legal & Regulatory - Other
Role: Legal & Regulatory - Other
Employement Type: Full time
Contact Details:
Company: Linux Laboratories
Location(s): Puducherry