Procter &
Gamble: Associate Manager Regulatory Affairs - P&G India, Pharmacy,
Medicine, chemistry, Biology, etc
Description
of the role:
Coordinate
Regulatory Life Cycle Management activities for India portfolio, Coordinate
with Local Regulatory Affairs for roll outs (expansions to white space),
variations, renewals, answering health authority requests.
Maintain
Master Dossiers and compile, review, and provide dossiers for local
registration and compliance to achieve registrations for the specific product
portfolio, Provide Regulatory input for Periodic Safety Update Reports (PSURs),
Periodic Quality Reports (PQRs), and Product Data Sheets (PDS). Advise
organization of potential regulatory risks in normal day to day activities and
recommend compliant actions. Liaise with Corporate Technical and Product Supply
functions to provide the current registered details of each product.
Ensure
regulatory assessments are conducted for change controls in the Quality
Tracking system. Ensure that the Regulatory Information Management system is
maintained and updated for all activities under role responsibility, including
review of documents.
Qualifications
Requirements
(skills / experiences) for the role:
Qualification:
Education: A minimum qualification of a degree in
any of the life sciences (pharmacy, medicine, chemistry, biology, etc.).
Nationality: Ability to work permanently in one's
country of residence
Languages: Proficient in English
Good
regulatory experience (minimum 5-7 years) preferably in consumer health and
preferably across multiple regulatory classification areas (health supplements,
medicines, etc.)
Experience in
the dossier maintenance and product change management
Good
experience with Regulatory database
Strong
initiative and follow-through with accountability for work quality
Excellent attention
to detail, good communication and presentation skills
Results
oriented and self-motivating with an ability to influence others
Proven
ability to handle competing priorities efficiently with
excellent interpersonal skills
Openness to change and ability to think out of
the box
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