Regulatory Affairs Recruitment in Abbott , Maharashtra

abbott

 

Abbott
Maharashtra,India

Associate, Regulatory Affairs-1500000DDS
Description:
Primary Job Function:
Tracks registration activities and status to deliver on-demand reports that meet internal business needs and regulatory authority requirements
Communicate with affiliates in order to track submissions and the submission status
Analyzes reports and metrics from tracking tools; identifies trends and ramifications.
Contributes to Regulatory systems project to assure business needs are met and optimized for efficiency and effectiveness.
Core Job Responsibilities:

  • Provide Registration tracking and commitment input and reporting
  • Advice and counsel to cross-functional disciplines including the Regulatory sub teams, Pharmacological, Labeling and affiliate members
  • Represent registration management on Regulatory sub teams as necessary, elevate timeline issues
  • Act as registration management representative on cross-functional teams such as process improvement teams.
  • Implement internal process and standards relating to registration management
  • Responsible for the evaluation, implementation, testing, validation of software updates or enhancements
  • Issue/problem resolution for registration management system
  • Contribute to training materials
  • Participate in team meetings
  • Compile and escalate compliance information via MTR (Monthly Tracking Report)
  • Distribution and maintenance of  MTR Information
  • Provision of compliance metric to support Pharmacovigilance processes
  • Assist in internal audits and inspections
  • Assist with global vigilance reporting and regulatory field actions such as recalls or corrections & removals
  • Submit data elements to EMA related to XEVMPD according agency requirements

Accountability:

  • Responsible for timely delivery of registration management output worldwide.
  • Works under limited supervision ensuring deliverable meets Abbott’s internal standards
  • Responsible for monitoring area of responsibility for changing Regulatory requirements that would impact the processes or systems
  • Accountable for tracking of complex worldwide submissions in the registration management tool
  • Accountable for tracking and updating of the registration lifecycle for  EPD related products in the registration management tool
  • Accountable for complex queries and reports from the registration management database distributed to stakeholders in- and outside EPD Regulatory.

Qualifications:

  • 2-5 years business related experience
  • Demonstrated ability to quickly learn new technology
  • Expertise with EDMS (Documentum based) and registration management systems
  • Knowledge of regulations and instructions

Demonstrated team-player
Job Classification: Experienced
Job: COMPLIANCE/REGULATORY AFFAIRS
Primary Location: India-Maharashtra-Greater Mumbai
Organization: EPD-EstPharmDiv
Schedule: Full-time
Shift: Day
Travel: Yes, 15 % of the Time

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Regulatory Affairs Recruitment in Abbott , Maharashtra

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