65 Job openings found

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 ...

Position:       AGM/GM - Quality  Location:       Daman Experience:   15 - 25 Years Industries:     Pharma Responsibilities: Site Quality Leadership: To establish and maintain a robust Quality Management System (QMS) aligned with regulatory expectations. To represent the organization as the Quality Management Representative during internal, external, and regulatory inspections, ensuring successful outcomes and continuous compliance readiness. Quality ...

Position:         RA Executive (Khopoli) Location:        Khopoli - Raigarh Experience:     5 - 6 Years Industries:      Pharma    Responsibilities: Dossier Preparation & Submission Prepare, compile, and review CTD / ACTD / eCTD dossiers for product registration in global markets. Coordinate for ANDA, DMF, CEP, COS, and other regulatory submissions for APIs and ...

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 ...

Position:      Asst. Manager - QA Location:      Daman Experience:  8 - 15 Years Industries:    Pharma Responsibilities: To maintain a robust Quality Management System (QMS) aligned with regulatory expectations. To handle internal, external, and regulatory inspections, ensuring successful outcomes and continuous compliance readiness. To handle compliance of deviation management, change control, Market Complaint Recall, ...

We are seeking an experienced QA/QC General Manager to lead and oversee all Quality Assurance and Quality Control functions within a manufacturing environment. The ideal candidate will be responsible for ensuring compliance with regulatory requirements, maintaining robust quality systems, driving continuous improvement initiatives, and managing laboratory and quality operations. This role ...