Panacea Biotec Limited Deputy / Assistant Manager – Regulatory Affairs (ICH) Deputy
/ Assistant Manager – Regulatory Affairs (ICH)
Job Description To
provide the regulatory strategy for the specific product (s) for the selected
markets as per PIF/marketing requirements
To provide the development/data requirements as per the
specific country (ies) regulatory requirements
Working for the post approval life cycle management of
approved ANDAs US Dossiers and data compilation and coordination with internal
and external stakeholders
Dossier compilation in CTD format for submission to ICH
region (US) and other regions such as Australia, New Zealand etc for solid
orals dosage forms.
Document compliance of different dossier documents for
adequacy and accuracy. It includes mainly CMC Documents, Vendor document,
Pharmacokinetics study protocols and reports
Well verse with eCTD and SPL (Structured product labeling).
Coordination with all involved parties in a product life
cycle in product development, dossier compilation, query phase and post
approval changes.
Management of dossier data and updating scientific
information within organization in the field of regulatory.
Impact analysis on submitted dossiers during assessment phase
due to change in regulations or requirements.
Liasoning with project management team for maintaining timelines
for dossier submission.
Dossier document review, correction, adequacy and accuracy
check.
Coordination with other internal and external parties in dossier
/query compilation stage.
Should have understanding of review of open part of DMF’s/CEP
Package/Technical Package
Experience 6-08 Years
Age 34-40 Years
Industry Type Pharmaceutical
Research and Development
Functional Area Formulation
Research Development
Education M. Pharm.
(Pharmaceutical Analysis & Quality Assurance
Compensation At
par the Industry
Department Regulatory
Affairs Research & Development
Location Lalru –
Punjab
Contact Manoj
Kumar, Panacea Biotec Ltd.
Email manojkumar1@panaceabiotec.com
Website http://www.panaceabiotec.com/
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