68 Job openings found

  Preparation and review the dossier of as per current prescribed guidelines of the respective regulatory authority. Well versed with the guidelines of ICH and other regulatory. Preparation of documents for license application. Preparation of documents for COPP, FSC and other legal documents including product permission Preparation of registration documents as per ACTD , CTD ...

JOB DESCRIPTION Assistant Manager – Purchase Position Details Position Title Assistant Manager – Purchase Department Purchase / Procurement Location Corporate Office Reporting To Manager – Purchase / Head – Procurement Industry Pharmaceutical Manufacturing Role Type Procurement / Strategic Sourcing / Vendor Management Job Purpose To ensure uninterrupted availability of raw materials, packing materials, engineering items, consumables, and services required for pharmaceutical manufacturing operations through ...

Must be Graduate/Post Graduate with about 3 to 4 years in working for Industrial Project in Chhattisgarh. Canditate must be based at Raipur         The Liaisoning Officer is responsible for establishing and maintaining effective communication and coordination with government departments, regulatory bodies, local authorities, and other external stakeholders. The role involves managing ...

DMF API Submission experience is must Preparation of New Drug Master Files as well as DMF amendments for Brazil, US, and ROW market according to respective agencies requirements. Preparation of Applicant part of DMF for Brazil, US, and ROW market. Preparation of all administrative statements for respective authority requirements. Drafting of regulatory response for ...

Job Description   -Compilation and submission of eCTD dossier for new product application (ANDA/EU-MA)/Post approval submission to the regulatory authority (specifically EU/US) -Hand on experience in preparation of CTD section as per regulatory requirements of different region -Having experience in preparation of query response and PAS, CBE and annual report. -Have ability to co-ordinate with ...

ompile, author, and maintain Type III Drug Master Files (DMF) for the US FDA, Health Canada, and equivalentregulatory submission dossiers for European (EDQM) and Asian regulated agencies.Coordinate the preparation of comprehensive technical dossiers covering raw materials, master-batchcompounding matrices (Halobutyl polymers), formulation ingredients, and vulcanization traits.Manage the swift completion of annual ...

Sound knowledge and experience in completing full life cycle of any ISTS project from regulatory aspects. Essential knowledge of requirement of permits and approval for an ISTS project like Sec 68, Sec 164 before and after COD including during construction. Must possess experience in Testing procedure, First Time Charging (FTC), Trial ...

The Regulatory affairs team supports all the departments within the organization towards all regulatory requirements including approvals, reports, information sought etc. Such regulatory offices include DGCA, Various Ministries, AAI etc. The official under the role w The Regulatory affairs team supports all the departments within the organization towards all regulatory requirements including approvals, reports, information ...

  Job Description: Regulatory & Compliance Manager     1. Position Description   Job title Regulatory & Compliance Manager     Department QA Reports to Vice President-R&D Direct Reports - Location Daman       2. Job Purpose   Job Statement Job purpose Ensuring that our master batch and additive solutions meet or exceed the compliance expectations of customers, certifying bodies, and regulatory agencies in both domestic and international markets   3.  Basic Qualifications   Job Requirements Education M.Sc / ...

We Are Hiring API Export Manager In Ahmedabad Job Title: International Sales/Exports PositionsLocation : Ahmedabad(Only Male Candidates Can Apply)  Job Title: API Export Manager  Key Responsibilities: Lead API sales growth in the GCC region by identifying, approaching, and developing new business clients. Manage and maintain strong relationships with existing customers, ensuring retention and satisfaction. Handle customer queries ...