Abbott India Limited is a subsidiary of Abbott Laboratories, USA, a global, iversified health care company devoted to the discovery, development, manufacture and marketing of pharmaceutical, diagnostic, nutritional and hospital products. The company now employs approximately 70,000 people and markets its products in 130 countries worldwide.
Post: Regulatory Quality Compliance Associate - AV
Job Description:
To strategies for regulatory approvals as per annual registration plans
To prepare dossiers and submissions for various regulatory fillings
To deal efficiently and effectively with regulatory agencies for regulatory issues.
Management of the complaint handling system and the adverse event reporting systems
To assist in handling various regulatory queries
To prepare and submit PSURS for four years after approval to the regulatory authority
To prepare and submit all PMS reports, Adverse Event Reports and other safety reports to the regulators
Technical Evaluation of the dossiers and files obtained from US regulatory for submission in India
Regularly gets updated and self trained with the latest regulations on Medical devices in the country
Liasioning with the Regulatory agencies both at centre and state level
Scrutiny and internal regulatory Audits of Quality system as per guidelines and SOPs
Creates / develops regular checklists based on overall business regulatory plans as assigned.
Evaluates the adequacy and compliance of systems, operations and practices against regulations and company documentation
Tracks issues through to closure including reviewing corrective action taken
To implement/coordinate changes per field notifications received from Manufacturing sites (stop shipment, recalls etc)
Additional Information:
Exp: 2-6 yrs
Location: Mumbai
Education: B.Sc. or B.Pharma with Diploma in Regulatory Affairs
Industry Type: Pharma/ Biotech/Clinical Research
Functional Area: DRA
Keyword or Job ID: 108593BR
End Date: 5th March, 2012
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