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
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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