Associate, Regulatory Affairs-1500000DDS
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
- 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.
- 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
Job Classification: Experienced
Job: COMPLIANCE/REGULATORY AFFAIRS
Primary Location: India-Maharashtra-Greater Mumbai
Travel: Yes, 15 % of the Time
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