Abbott Associate Registration Management in Mumbai, India
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, Pharmacovigilance, 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
• Distribution of updates to Company Core Data Sheets (CCDS) using a Source Document Change Notification (SDCN)
• 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.
Bachelor or Master Degree in Information Management, Bio Science, Business Administration or equivalent.
Minimum Experience/Training Required:
• 1-4 years business related experience
• Demonstrated ability to quickly learn new technology
• Expertise in RIMS & registration management systems
• Knowledge of regulations and instructions
• Demonstrated team-player
An Equal Opportunity Employer
Abbot welcomes and encourages diversity in our workforce.
We provide reasonable accommodation to qualified individuals with disabilities.
To request accommodation, please call 224-667-4913 or email email@example.com
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