Lifescience Intellipedia Pvt Ltd Job Vacancy for B Pharma/ M Pharma
Looking for Regulatory Affairs- eCTD to join our Lifescience Intellipedia team.
Qualification: B. Pharm/ M. Pharm
Preference: Diploma in DRA
Experiences: 2 years to 3 Years
Location: Noida Sector-65 Salary: Negotiable
Role & Responsibility:
-Relevant experience for regulated market.
-Compilation of NDA & ANDAS.
-Expedience with eCTD.
-Hands on experience in review and compilation of Modules
-Dispatch dossiers/samples/working standards etc. for Europe, Canada, Brazil, USA & Australia as per CTD/ eCTD format & Knowledge of OSD, Liquid, Injection & Ointment.
-Handling Queries of regulatory submission.
-Registration/ re- registration Review of Analytical method validations, method transfer protocol and Reports.
-Good experience in database searches which are required for ANDA filing.
-Familiar with ICH guidelines.
-Should have experience in variation filing.
-Able to coordinate with cross functional teams QA, QC, R&D and Production for technical documents required for Regulatory -publishing and submission.
interested candidates can share their resume on
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