Senior Executive-Regulatory Affairs

2 weeks ago

Mumbai, Maharashtra, India Piramal Enterprises Full time
Job Description

Job Description :

Business: Piramal Critical Care
Department: Regulatory Affairs
Location: Kurla
Travel: Low

Job Overview

The Executive Regulatory Affairs is responsible for theportfolio of Piramal Critical Care/Piramal Pharma Ltd products in the ROW and Latam region(s). He/She will be the primary point of contact with the manufacturingsite in the USA, INDIA, CMO (Contract Manufacturing sites) and will be responsible for the coordination of document requests in support of global regulatory submissions. The incumbent will also assess, manage, and track change controls from regulatory perspective for the US/India/CMO and facilitate regional or global regulatory assessments within the RA department. Also he/she will be responsible for obtaining documentation to support the compilation and submission of DMFs, CTD , ACTD and Regional Dossiers, Variation/Renewal filings, Support to APQR's, Tender Filings, OEF approvals, Sample arrangements/dispatch and maintenance of regulatory database / repositories.

Essential Duties and Responsibilities

- Serves as the primary point of contact with the US / INDIA / CMO facility for the coordination of document requests in support of global regulatory submissions
- Assesses,manages and tracks changecontrols for the US/India /CMO sites and facilitates regional or global regulatory assessments within regulatory affairs department
- Reviews the regional website for relevant updates or notifications for new regulations and guidance documents.
- Supports global regulatory submissions by obtaining complementary elements such as CPPs, Apostilled and Legalized documents
- Obtains documentation from various departments to support the compilation and submission of CTD , ACTD and Regional Dossiers, Variation/Renewal filings, Tender and Special Import Filings
- Compiles and submits amendments to Drug Master Files for the Regional ROW markets.
- Assists in managing the Renewal/Retention of registrations for Human/Veterinary drugs in the ROW and LatAm markets
- Assists as needed with both pre-market (Company / Site Registration/GMP approvals) and post market submissions (Variations) in the ROW and LatAm markets
- Coordination with Labelling and Artworks teams for generation of Standard / Country Specific artworks/Packaging.

Essential Education/Experience Required

- M-Pharm, B-Pharm, MSC, in scientific discipline or equivalent education.
- Minimum of 6 Month to 2 years of regulatory affairs experience required
- Previous experience / Knowledge of Regulatory Dossier preparations.
- Strong knowledge of FDA and ICH guidance documents
- Good Manufacturing Practice (GMP) knowledge required

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