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Regulatory Affairs - Formulation Division

3.00 to 7.00 Years   Hyderabad   22 Feb, 2022
MSN Laboratories Pvt Ltd
Job LocationHyderabad
EducationNot Mentioned
SalaryRs 2.5 - 6 Lakh/Yr
IndustryPharma / Biotech
Functional AreaR&D / Product Design
EmploymentTypeFull-time

Job Description

    We are looking for candidate those who have experience in Regulatory affairs ( US & Europe Market) in Formulation Div.Department:- Regulatory AffairsDivision :- FormulationExperience : - 3 to 7 YearsJob Description:-
    • Experience in handling regulatory affairs for ROW , US & EUROPE market 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 Informations) 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.

Keyskills :
regulatory affairswhous market

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