Job title: Associate – Registration Management(XEVMPD)
Company: Abbott
Job description: JOB DESCRIPTION: List the primary tasks and/or activities this job performs on an ongoing basis. * Provide Registration tracking and commitment input and reporting * Advice and counsel to cross-functional disciplines including the Regulatory s
JOB DESCRIPTION: List the primary tasks and/or activities this job performs on an ongoing basis. 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 Master Data Management The salary for this role is between: N/A JOB FAMILY: Regulatory Operations DIVISION: EPD Established Pharma LOCATION: India Mumbai : BKC Building ADDITIONAL LOCATIONS: WORK SHIFT: Standard TRAVEL: Yes, 25 % of the Time MEDICAL SURVEILLANCE: Not Applicable SIGNIFICANT WORK ACTIVITIES: Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)
Expected salary:
Location: Mumbai, Maharashtra
Job date: Sat, 15 Oct 2022 22:15:53 GMT
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