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QC Regulatory Affairs Department (API)

Pharmaceutical (API )

We have a Job Opening for the position of Sr. Officer / Executive – Regulatory Affairs Reputed Pharma API Company @ Vadodara Loaction ( For Regulated Plant USFDA/MHRA) Interview Conduct On Telephonic ? Industry Type – Pharma API Plant ? Position – Sr. Officer / Executive – Regulatory Affairs ? Education – M.SC/B.SC/M.PHARM/B.PHARM ? Experience Required – 3 to 7 Years ? CTC- Negotiable About Company: They have an International Presence in over 35 Countries. It’s a WHO-GMP & ISO , MHRA, FDA, Republic of turkey , Ministry of Health Certified Company. 13 Years Old group Pharma (Manufacturing API & Formulation Plant). MFG Location in Gujarat : Vadodara , Dhabasa Upcoming API Facility with Capacity Upto 450 TPA Our Manufacturing Site complies with local Regulatory requirements and general principles. Having 15+ DMF & ANDA FILED 15+ Molecules Under Development & Drug Development Expertise for Complex Molecules Business Associate of NAVINTA USA & WAYMADE UK Products: ANTI-CANCER, RARE DRUGS, RENAL CARE, HAEMATOLOGICALS, CARDIOVASCULAR, CNS, ANTI-RHEUMATIC, ANTI-DIABETIC, INTERMEDIATES, EXCIPIENTS Job Responsibility: Compilation of ANDAs for regulatory Submission. Preparation of the ANDAs Sections. Responsible for eCTD Publishing of ANDA. Preparation of the DMFs Sections like; Module 1, Module 2(QOS), Module 3. Responsible for eCTD publishing of DMFs, Annual reports and amendments. Compilation and submission of SPL for API. Handling of queries raised during the review of USDMF. Compilation of applicant part and restricted part as per customer requirement. If Interested Candidates send us updated CV at resume@opeconjobs.com/cv@opeconjobs.com Or Call/ WhatSapp on 9099101551/9723551551 Regards, Dharti Pandya (Team – Opecon) Ankleshwar M : 9099101551/9723551551