Manager Registration Management
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Job Location:
Monthly Salary:
Posted on:
7 hours ago
Vacancies:
1 Vacancy
Job Summary
JOB DESCRIPTION:
Role Purpose
Provide strategic and operational leadership for Regulatory Information Management (RIMs) to ensure accurate compliant and timely management of global regulatory data product lifecycle activities and inspection readiness.
Key Responsibilities
- Lead and develop a highperforming RIMs team to deliver seamless daytoday regulatory operations.
- Oversee creation and maintenance of regulatory applications for NPIs safety variations and lifecycle activities.
- Provide subjectmatter expertise and operational support for regulatory activities managed within centralized RIMs systems.
- Manage workflows for timely delivery of critical regulatory reports (e.g. Status Product Quality WWMAS) supporting supply manufacturing PV inspections and governance.
- Own XeVMPD submissions and ongoing maintenance of registered product data.
- Ensure accuracy integrity and completeness of registered product and master data across global markets (LATAM METAP APAC EU India and others).
- Maintain and update SOPs and Work Instructions for assigned workstreams ensuring continuous audit and inspection readiness.
- Support regulatory audits and health authority inspections through RIMs expertise data extraction and documentation.
- Lead User Acceptance Testing (UAT) and related testing for new features system enhancements or major RIMs implementations.
- Drive continuous improvement data quality excellence and compliance with global regulatory requirements.
- Manage team performance capability building and career development.
Required Expertise
- Strong knowledge of global regulatory regulations and guidelines.
- Handson experience with industrystandard RIMs tools and regulatory systems.
- Proven people leadership and stakeholder management capability.
The base pay for this position is
N/AIn specific locations the pay range may vary from the range posted.
JOB FAMILY:
Regulatory Operations
DIVISION:
EPD Established Pharma
LOCATION:
India > Mumbai : Mumbai Development Center - EPD
ADDITIONAL LOCATIONS:
WORK SHIFT:
Standard
TRAVEL:
Not specified
MEDICAL SURVEILLANCE:
Not Applicable
SIGNIFICANT WORK ACTIVITIES:
Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)
Required Experience:
Manager
About Company
WHO WE ARE CREATING LIFE-CHANGING TECHNOLOGY From removing the regular pain of fingersticks as people manage their diabetes to connecting patients to doctors with real-time information monitoring their hearts, from easing chronic pain and movement disorders to testing half the world’s ... View more
