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Work for M.Sc. or M.Pharma as Senior Regulatory Affairs Associate in Abbott - only 4-5 years of candidates

 

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Abbott India Limited is a subsidiary of Abbott Laboratories, USA, a global, diversified 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: SENIOR REGULATORY AFFAIRS ASSOCIATE-14000005TA

Job Description

  • Technical Evaluation of the dossiers and files and compilation for submission in India
  • Execute strategies developed for regulatory approvals as per annual registration plans
  • Working cohesively with Business Unit on the additional requirements for the product approval, response to queries
  • Work with Labeling team to be compliant to India Specific labels as per local regulation
  • Manage Product Release Approval (PRA) Release post approvals and India Specific labels are released
  • Support Sales team with regards to any regulatory documents required for tender approval
  • Identify major regulatory and compliance risk and threats to the overall business in India and update the
  • management regarding the same
  • Closely work with Management Representative for India to provide updates on Quality and Compliance issues and also support in India Management Review Meetings with timely inputs.
  • Support management of the complaint handling system and prepare analysis report for the management review
  • Coordinate with India Marketing team
  • Support Field Safety Corrective Action / Recall, Corrective & Preventive Actions (CAPA)& Stop Shipment
  • Support Internal & External Quality & Compliance Audits
  • Support management of ATMS trainings and assign trainings to all new employees within 14 days of joining. Also monitor relevant trainings assigned to all employees with respect to their job functions in India.
  • Provide feedback on the new procedures (SOP or DOP) being developed by International quality & compliance team
  • Prepare and submit all PSURS, PMS reports, Adverse Event Reports and other safety reports to the regulators
  • Regularly gets updated and self trained with the latest regulations on Medical devices in the country
  • Networking and Liasioning with the Regulatory agencies both at centre and state level
  • Creates/ develops regular checklists based on overall business regulatory plans as assigned.
  • Support Evaluation of adequacy and compliance of systems, operations and practices against regulations and company documentation
  • Tracks issues through to closure including reviewing corrective action taken

Qualifications
M.Sc. or M.Pharma with specialization in Regulatory Affairs
4 -6 Years of Experience in Regulatory Affairs department.


Additional Information:
Experience:
4-6 yrs
Qualification: M.Pharm, M.Sc
Location: Delhi
Industry Type: Pharma / Biotech / Clinical Research
Functional Area: DRA
Last Date: 10th July, 2014

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