Medley Pharmaceuticals Ltd Hiring ASSISTANT
MANAGER- REGULATORY AFFAIRS B.Pharma / M.Pharma / MS/M.Sc(Science) / B.Sc - Any
Specialization
Job Description
Coordination and review for administrative
data required for dossier submission.
Coordination with Production, Store, QC and
R&D for archival of regulatory samples, packing component, Working standard
& analytical data
Monitoring of New Material Introduction and
New Product Introduction activities for ANDA & EU Dossiers.
To prepare requirement for FDA applications
related to FSC, COPP, additional product license, tender documents etc.
To maintain license documents and other FDA
documents.
Review and Co-ordination for the Gap
Analysis for the Regulatory News Letters and follow ups for the closures of
identified actions.
Coordination, tracking and follow up with
production and IPQA concerned for Sample requirement for various countries.
Providing registration details along with
registration certificates to plant concerns in coordination with RA-HO.
Review and issuance of Registration compile
status and respective addendum to all plant concerns within stipulated period.
Reviewing and approval of product
conversion form for different country based on need of International business
in coordination with Regulatory Affairs –HO.
Reviewing and approval of BMR, BPR on
behalf of Regulatory affairs.
Preparation of various MHRA correspondence
letters for QP and third party Contact person for variation and Market
complaint explanation
Preparation and Review of Annual Product
Quality Review.
Preparation and Review of SOP.
To ensure continuous system improvement by
reviewing documents and carrying out self-inspection of various departments in
the plant.
Evaluation, review and closure of change
control, deviation, FIRCAR, CAPA, Market complaint, NMI, NPI, Periodic
Extension and Quality Risk Management.
To assist investigation of market
compliant, deviation and other non-conformances reported.
Timely escalation of open QMS documents.
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