OFFICER

Purpose - Responsible for ensuring regulatory compliance through effective management of statutory licensing activities, including procurement, renewal, amendment, and maintenance of licenses and approvals from State FDA, CDSCO, CBN, WHO, and other regulatory authorities to support uninterrupted manufacturing and export operations. Position / Job Title -Officer Department- Corporate Quality Assurance (CQA) Reporting To -Sr Manager CQA Location -Thane, Mumbai Years of Experience - 1 - 3 Years Dosage Form -All applicable dosage forms (Oral solid, Nasal, Liquid oral, Topical, Injectable) Job Responsibilities / Deliverables • State FDA Licensing -Obtain, renew, amend, and maintain manufacturing licenses issued by the State Food & Drug Administration (FDA) -Prepare and submit applications for: Form 25& 28 - Manufacturing License Form 29 - Test License for Examination Test & Analysis and Bioequivalence Study -Coordinate approvals for addition/deletion of products, manufacturing blocks, dosage forms, and technical staff. -Liaise with State FDA officials for inspections, approvals, and regulatory compliance • CDSCO Licensing -Prepare, submit, and track applications through the CDSCO SUGAM Portal -Coordinate statutory approvals including: Form 11 & CT-17 - Import License CT-11 / CT-14 - Test License NOC Export NOC Dual Use NOC -Coordinate responses to CDSCO deficiency letters and regulatory queries -Liaise with CDSCO officials and consultants to obtain approvals within defined timelines • WHO-GMP Licensing -Prepare, submit, and track applications through the ONDLS Portal -Prepare and obtain: COPP (Certificate of Pharmaceutical Products) Renewal WHO-GMP Certificates -Maintain compliance with the WHO requirements. • CBN (Central Bureau of Narcotics) Licensing -Coordinate applications and renewals related to NDPS -Prepare and obtain: Import Certificate for NDPS materials Export Authorization for NDPS products Import NOC -Maintain statutory records and documentation required under the NDPS Act and Rules -Coordinate annual quota applications, utilization reports, and regulatory inspections by CBN • Documentation & Compliance Management -Maintain a centralized repository of: Manufacturing Licenses Import Licenses Test Licenses Export NOCs Dual Use NOCs NDPS Import/Export Authorizations COPPs Government correspondence Inspection reports -Ensure all licenses remain valid and applications for renewal or amendments are submitted well before expiry • Regulatory Liaison -Serve as the primary point of contact with State FDA, CDSCO, CBN, WHO certification authorities, and other statutory bodies -Coordinate inspections, meetings, and submission of regulatory documents. -Follow up on pending applications to ensure timely approvals Qualifications & Pre-Requisites Bachelor of Pharmacy / Master of Science Experience in state and national licensing requirements Additional notes It would require travelling across Rubicon sites for local FDA audit support during the various regulatory / customer audits at manufacturing sites. Also, had to travel to local FDA and CDSCO offices as per requirement