Sr Ra/ Executive - Dra - Canada / Europe @ Extrius Consultants

Job Description

Leading Pharma Company

  SR RA/ Executive - DRA - Canada / Europe / South Africa/ US - Mumbai   Responsible for compilation, reviewing and processing regulatory submission Executive - DRA - Europe Market - Mumbairequirement for Solid and Transdermal dosage form. Collect, review and verification of quality documents viz. QbD based product development reports, quality overall summary, master and executed production and packaging records, stability study protocol and report and all other documents pertaining to product registration in compliance with compendial standards. Responsible for the preparation and peer review of quality regulatory submissions to ensure timely approval Person should have knowledge about PAS submissions. CB030 and CR /IR cycleResponsible for the maintenance and timely completion of regulatory documents to support regulatory compliance in US markets. Accountable for assessing, coordinating and compiling deficiency responses in a timely manner .Prepare and peer review labelling, product monographs and marketing materials.Review of change control documents. Additionally, Keeping the CMC team updated of any potential issues which may affect the quality of the documentation or submission timelines. To handle pharmacovigilance activity after commercialization e.g. PADER submissions, ICSR updates etc. Create hyperlinking, bookmarking, OCR conversion etc. in final dossier as per e-CTD requirements for ANDA. Accountable for assessing, coordinating and compiling quality deficiency responses in a timely manner.     Thanks & Regards, Priyanka Agarwal   Extrius Consultants & Services Recruitment Manager Pharma , Healthcare , Chemical & AV Contact : hidden_mobile E: hidden_email  

Employement Category:

Employement Type: Full time
Industry: Pharma / Biotech
Role Category: Product Management
Functional Area: Not Applicable
Role/Responsibilies: Sr Ra/ Executive - Dra - Canada / Europe /

Contact Details:

Company: Extrius Consultants
Location(s): Mumbai

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Keyskills:   regulatory change control protocol ocr compliance marketing records regulatory submissions regulatory compliance av product development monographs completion product registration healthcare dra pharma packaging control cmc