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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

Position Accountability/Scope:

• 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.

Minimum Education:

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 corpjat@abbott.com

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