Regulatory Affairs (RA) @ Grey Matter Robotics

Job Description

We are looking for competent experienced professionals to be an integral part of our team for our Formulation plant located at Jarod Savli, Vadodara (Gujarat) We Bharat Parenterals Ltd. is a Gujarat based pharmaceutical company, established in 1992 by Mr. Ramesh Desai, who started the company with a vision of making world class affordable medicines and to take it to the forefront of contract manufacturing units in Gujarat. Under the chairmanship of Mr. Desai, the company has moved ahead as a research driven and forward looking pharmaceutical company with a dedicated facility for antiretroviral drugs added over time to its already existing facility of general and B-lactum group of drugs. At Bharat Parenterals Ltd. We engage in efficient research, development, manufacturing, marketing, sourcing and distribution of the high-quality and top quality pharmaceutical products. As a fully integrated company we have in-house R&D, business development, manufacturing and regulatory compliance. capabilities. Job Responsibility for Officer/Executive Position: 1. Preparing reviewing and submitting product dossiers as per CTD (Common Technical Documents), ACTD, ROW Countries as per guidelines. 2. Preparing reviewing and submitting renewal documents/ renewal dossiers/ Variations/ responding to queries raised by Regulatory authority. 3. Involved in Co-Ordination with Plant, R&D and QA-QC Department for preparation and receiving & reviewing of technical Documents as DMF, Stability data, etc. and also arranging for the samples required for submission along with the product dossier

Employement Category:

Employement Type: Full time
Industry: Pharma / Biotech
Role Category: Purchase
Functional Area: Not Applicable
Role/Responsibilies: Regulatory Affairs (RA)

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Keyskills:   Regulatory compliance CTD Coordination RD QAQC DMF Product dossiers ACTD ROW Countries Renewal documents Variations Plant Stability data