Specialist @ Novartis India, Chemistry,
Pharmacy,
Biology
Job
Description
Position
Purpose
Implements
regulatory maintenance activities and second wave submissions to achieve
targets and business objectives in accordance with the submission plan to avoid
stock-outs and delayed launches. Ensures that preparation of variations follow
established processes and timelines. Acts as interface between the local
functions (NTO/ESO/QA) as well as all Sandoz development/maintenance centers to
ensure continuous compliance with legal, scientific (technological), ethical and
administrative requirements.
Major
Accountabilities
• Preparation
of regulatory maintenance submissions, variations, renewals and second wave
submissions, Modules 2 to 5.
• Supports in
submission preparation to ensure implementation dates of variations and file
availability dates of second wave submissions are met.
• Implements
proposed changes and provides regulatory input for worldwide regulatory impact.
• Contributes
to performance and KPI's of the team to deliver agreed targets and objectives
and supports reporting.
• Provides
DRCs/MRC sites/BD Regulatory, manufacturing business units with proper data and
change evaluations to plan and implement registration activities and to meet
commitments and requests of deficiency letters.
• Ensures that the escalation process to next
or higher-level management is followed, as applicable.
• Supports in
deficiency responses and rejections.
• Supports in the receipt of proper product
transfers from DRCs and BD Regulatory.
• Supports
regulatory consultancy for products and NTO.
• Ensures
proper data management
Key Performance
Indicator
KPI's, as
on-time file availability of second wave submissions and variations dispatched
to IM&S, deficiency rate, rejection rate, compliance
Minimum
requirements
Scientific
academic degree, preferably in natural science (chemistry, pharmacy, biology or
equivalent) - Masters or Bachelors Good written and spoken English. Local
language is an advantage
• At least 5
years of relevant experience in the domain of regulatory with an exposure of
working in global organization in generics is preferred.
• Exposure
towards project management is a plus
•
Well-structured, result-oriented, highly self-committed, resilient, flexible,
team player
• High
operational excellence orientation
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