Division
: Medical Research Division
Location : Mumbai
Job Profile :
- Provide
tactical and strategic inputs to New Product Committee in relation to
registration and regulatory approvals for new products and business
development.
- Will
co-ordinate with other Divisions within Pfizer India, PPG and other
Pfizer Divisions for Regulatory Affairs.
- Will
handle all issues relating to new product registration, including preparation
/ customisation of dossier, submission, correspondence, and follow-up
to closure of outcome.
- Will
be a member of the new product committee and would implement regulatory
strategy and provide time and feasibility estimates.
- Will
be responsible for assuring maintenance of approval status for all marketed
products, including proactive suggestion of strategies when appropriate,
and measures for regulatory safeguarding and defence of marked products,
if required.
- Will
be responsible for maintaining all regulatory documentation in compliance
with country regulations and PPG procedures.
- Will
oversee all local labeling activities described in SOP INDIA-REG-01.
The Labeling Officer will report in to this position.
- Will
oversee adverse event monitoring and reporting activities with regard
to local spontaneous reports as described in SOP INDIA-AEM-02 and PPG
India clinical trail generated reports. The Safety Officer will report
into this position.
- Will
manage regulatory action related to associated markets such as Nepal
and Sri Lanka.
- Will
set targets and objectives for direct reports and will facilitate and
assess their performance.
- Will
be responsible for estimation of regulatory costs and will have them
incorporated into the Medical Division budget.
Qualification & Experience :
- A graduate or post-graduate degree in Pharmacy, Pharmaceutical Medicine, Pharmacology, or any other pharmaceutical regulatory discipline.
- Should have 5-8 years experience in Pharmaceutical Regulatory Affairs.
Date
of Posting : 09/09/2005
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