Executive - Regulatory Affairs

Visualizza: 106

Giorno di aggiornamento: 06-05-2024

Località: Rudrapur Uttarakhand

Categoria: Legale / Contratti

Industria: Pharmaceutical & Life Sciences

Posizione: Regulatory Affairs Manager

Tipo di lavoro: Full Time, Permanent

Esperienza: 2 - 4 years

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Contenuto del lavoro

Roles and Responsibilities

.Experience in handling regulatory affairs for ROW market mainly 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 & ensures them to correct the documents.
Handling RFIs (Requested Further Information’s) queries raised by Importer/ Agent/ Regulatory authorities during evaluation of technical data.
Coordinating concerned (QA, QC, Production, Packing & Purchase) departments in the process of sample preparation.
Coordinate & submission of CTD/ACTD/Country Specific Dossiers/DMF (OP) to regulatory agencies.
Coordinate & provide support to team for preparation and dispatch of regulatory documents & dossiers in agreed time-frames.
Responsible for planning, coordinating and managing day to day regulatory affairs activities in a timely manner.
Providing technical knowledge of the data used in CTD, ACTD & Dossiers to members of regulatory team.
Fill up customer questionnaires by collecting information from various concerned departments.
You should be good in man - management & co - ordination with all the departments
Interact with various administrative, legal & factory departments to collect documents required for regulatory compilation on time.
Maintenance of the complete history of each drug product.

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