9 Copp Jobs

Responsibilities: CTD/ ACTD Process Validation (PV) BE Study Stability PDR Art work Check BMR/BPR Preparation SMPC Leaflet flit Preparation (Insert) AMV CDP Match Spect COA/MOA Finish Specifications Self-Prepared and Review

Designation : Associate - Regulatory Affairs Department : Regulatory Affairs Working Days & Timing : Mon to Fri (9am -6pm) Location : Worli, Mumbai. JOB RESPONSIBILITIES Artwork Management: Initiation and Checking: Initiating and monitoring of Registration artworks for ROW markets as per country Specific requirements, country labeling guideline and customer requirements. Checking of commercial and codification artworks for ROW markets as per country Specific requirements. country labeling guideline and customer requirements. Update commercial and codification artwork in artwork database. COPP Application: To prepare and apply for COPPs as per regulatory requirements for WHO and non-WHO produ...

Expertise: Deep, practical knowledge of Indian regulatory frameworks (FDCA, CBN, CDSCO) and demonstrable experience in dossier compilation for international markets. Looking candidates for liasoning work of loan licenses, pp, copp, noc, cbn work.

Job Opening: Graphic Designer Pharmaceutical Packaging Location: Pune, Maharashtra Employment Type: Full-Time Experience Required: 6 months to 1 year Industry: Pharmaceutical / Healthcare B.Pharm graduate (mandatory) Prior experience in import & export procurement (pharma/healthcare industry preferred) Knowledge of supply chain, vendor management, and logistics Familiarity with regulatory and compliance documentation for pharma exports (WHO-GMP, COA, COPP, etc.) Strong MS Office/Excel skills and comfort with digital procurement tools Excellent negotiation, communication, and coordination skills What you'll do: Manage supplier sourcing and negotiations for pharma and healthcare products Coord...

Roles and Responsibilities Should Have Formulation Experience. Having vacancies in RoW (ASIA , MENA, LATAM, AFRICA) Regions Responsible for product registration RoW (ASIA , MENA, LATAM, AFRICA) Regions region Preparation, compilation and review of dossiers for region in eCTD/CTD/country specific format. Co-ordinating with cross functional departments like API, R&D, QC, QA, PDD, Micro for documents required for dossier compilation for initial submission, query responses or other submission like tender activities. Communicating with agents/partners for submission of Dossiers and further updates or requirements if any on product registration. Responding to queries with in the time lines receive...

Role & responsibilities Preparation of country specific certificate of pharmaceutical product (COPP), Product permission, Shelf-life extension, Additional pack size, Test license, Free sale certificate (FSC), Marketing manufacturing certificate (MMC), Approval of mfg. & analytical chemist. Review and sign of Shade Card as per country specific. Review and sign of Packing Material Specification. Review and sign of Raw Material Specification. Review and sign of In Process Specification. Review of Stability protocols. Sign all documents related to FDA work. Sign in Vendor addition/changes documents Review of regulatory documents requested by concern department. Compliance of TI sheet. Regulatory...

Drive sales and business development of APIs in international markets South Asia & Middle-East Manage existing customer accounts and build strong client relationships to ensure repeat business and customer satisfaction. Required Candidate profile Identify and onboard new international customers (formulation companies, traders, partners). Handle pricing, quotations, negotiations, Immediate to 30 days preferred

Job Profile for Regulatory Affairs : Participate and coordinate with various cross-functional teams by working closely with Quality assurance, Quality control for documents collections in dossier preparation. Dossier review and collection of required Pharmacology/Toxicology/Clinical data through literature&internetforpreparationofSummaryofProductCharacteristic and Patient Information Leaf lets (PIL). DMF Review Preparation and Management for submission of dossier in CTD, ACTD and Country specific format. Review of Analytical method validation verification Reports required for drug product development and submission in regulatory application. Review of stability data incompliance with specifi...

Roles and Responsibilities Should Have Formulation Experience. 1. Responsible for product registration in ROW (AFRICA, ANZ, ASIA, LATAM, CIS &, MENA). 2. Responsible and involving in the regulatory audits and coordinating with the auditors/customers. 3. Preparation, compilation and review of dossiers for RoW region in CTD /country specific format. 4. Co-ordinating with cross functional departments like API, R&D, QC, QA, PDD, Micro for documents required for dossier compilation for initial submission, query responses or other submission like tender activities. 5. Communicating with agents/partners for submission of Dossiers and further updates or requirements if any on product registration. 6...