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Associate Manager

2 months ago

New Delhi, India Abbott Laboratories Full time

RESPONSIBLE FOR

  • Execute strategies developed for regulatory approvals as per annual registration plans
  • Technical Evaluation of the dossiers and files and compilation for submission in India
  • 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 after India Specific labels are released
  • Support Sales team with regards to any regulatory documents required for tender approval
  • Coordinate with India Marketing 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
  • Support in Tracking emerging issues and identify solutions
  • Support Field Safety Corrective Action / Recall, Corrective & Preventive Actions (CAPA)& Stop Shipment
  • Support Internal & External Quality & Compliance Audits
  • Provide feedback on the new procedures (SOP or DOP) being developed by International quality & compliance team