20 Job openings found

Job Location : Mahape, Nearest Station Ghansoli (Navi Mumbai)   Look for people from Navi Mumbai or Mumbai Only   Only Female Candidates required   Qualification : B.Pharm / M.pharm   Experience : 1yr – 3yr   Salary : 1.42lpa – 2 .80lpa     Profile : Experience in preparing Dossiers in CTD, ACTD, Country Specific Dossiers.   Countries : ROW and Latum   Job Description: Dossier Preparation along ...

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 ...

  Key Responsibilities: Prepare, compile, and submit CTD/eCTD dossiers for EMA and DGMED (France) including new registrations, renewals, and variations. Coordinate with internal teams (QA, QC, R&D, Supply Chain) for document collection and compliance. Liaise with regulatory agencies and local representatives in the EU and France for query resolution and approvals. Ensure dossiers and product ...

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 ...

Job responsibilities are to Assist Regulatory manager: Preparation, Compilation and review of registration dossier of tablet /capsule/injection in CTD, ACTD as well as country specific format for countries Preparation, Compilation and review of registration dossier of capsule/syrup/balm in a Herbal products for country specific format in countries of African Region, Cambodia, Myanmar, CIS To manage ...

Job responsibilities : Preparation, Compilation and review of registration dossier of tablet /capsule/injection in CTD, ACTD as well as country specific format for countries Preparation, Compilation and review of registration dossier of capsule/syrup/balm in a Herbal products for country specific format in countries of African Region, Cambodia, Myanmar, CIS To manage new registration / preregistration ...

Job Description:  Experience in handling regulatory affairs for ROW market mainly Central and Latin American, African & Asian countries for Pharma Formulations. ? Preparation, Compilation & Review of Registration documents that include Administrative & Technical. ? Reviewing the technical documents provided by QA, QC, Production providing them the report of shortcomings & ...

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 Trainee(Khopoli) Location:        Khopoli - Raigarh Experience:     0 - 1 Years Industries:      Pharma    Responsibilities: Assist in the preparation and compilation of regulatory dossiers (CTD / ACTD / eCTD) for product registration in various markets. Support the collection and review of technical documents from R&D, QA, QC, and Production ...

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: ...