20 Job openings found

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 for API Regulatory: Preparation, review and submission of Drug Master Files/CEP in eCTD format for the regions US, EU through ESG and CESP. Life cycle management of the Drug Master Files (Amendments, Annual Reports, CEP updates). Preparation, review and submission of Applicant's Part DMF (Open Part DMF) and Technical data ...

COA/ Certificate of Analysis MSDS Specifications/ TDS Method of Analysis Stability Data DMF/ Drug Master File Declarations Preparation of Vendor Questionnaire Customer response for technical queries Must have knowledge of Pharmacopoeias, ICH guidelines   COA/ Certificate of Analysis MSDS Specifications/ TDS Method of Analysis Stability Data DMF/ Drug Master File Declarations Preparation of Vendor Questionnaire Customer response for technical queries Must have knowledge of Pharmacopoeias, ICH guidelines,

  Job Description -    20.12.24   HPS/2024/799 Maintainence Manager. Male 1 4 DMF / B.E (Mech)   Name of position: - Maintenance Manager Experience required - 4 years Qualifications required: - DMF / B.E (Mech) Age range: - Any CTC: 4.00 – 4.50 LPA Shift Timing: - General (9 am – 7 pm)    Skills required: - 1. Supporting and leading all Maintenance process & operations 2. Tracking ...

Key Responsibilities: 1. Method Development & Validation Develop analytical methods for assay, dissolution, related substances, and stability testing. Conduct method validation as per ICH guidelines (accuracy, precision, specificity, linearity, robustness). Optimize and troubleshoot existing analytical methods. 2. Instrument Handling Operate analytical instruments such as HPLC, GC, UV, FTIR, KF, Dissolution Apparatus, etc. Perform daily calibration and ensure ...

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 ...

Job Summary: We are seeking an experienced and dynamic R&D Sr. Manager / Manager to lead API process development and optimization projects. The role involves overseeing laboratory research, scale-up, and tech transfer of API processes, ensuring timely delivery, compliance with regulatory standards, and alignment with business goals. Key Responsibilities: Lead end-to-end API development ...

Position:          Officer/Executive – RA Location:         Paria - Vapi Experience:     2 - 5 Years Industries:       Pharma   Responsibilities: Compilation and review of regulatory dossiers (CTD, ACTD, eCTD) for CIS, LATAM (especially Brazil & Mexico), African, and EU regions. Handle full lifecycle of product registration including new submissions, renewals. Review technical documentation: ...

The Project Coordinator is responsible for planning, tracking, and coordinating pharmaceutical laboratory projects across departments such as R&D, Quality Control, Regulatory Affairs, and Production. The role ensures timely execution of tasks, documentation, and compliance with industry standards and project deadlines. 🎯 Key Responsibilities: Coordinate day-to-day activities of pharmaceutical lab projects (R&D, method ...

To review and implement a Quality Management System for cGMP compliance at the Production (Injectable) plant. To prepare, Review and Approve BMR, BPR and related documents. Handling of Caliber QAMS, DMS, Nichelon 5 CMS, Dynamic, Schedule and Track and trace Serialization & aggregation. Giving the required training also Responsible for Media fill and ...