Senior Regulatory Engineer responsible for regulatory strategies and agency interactions at Johnson Controls. Collaborating on new product approvals and maintaining compliance with existing products.
About the role
- Compliance & Oversight Lead Manager facilitating GILA business processes and data quality. Ensuring compliance with labeling activities in a global pharmaceutical environment.
Responsibilities
- Facilitate the GILA business process, data quality and compliance.
- Generating GILA project line listing & reports.
- Maintaining GILA SharePoint pages and Pfizerpedia.
- Contributing to labeling processes via specific business cases, job aids, work instructions, etc.
- Performing routine process and quality monitoring.
- Supporting investigations for QE activities for above country issues.
- Analyzing system data to ensure data quality.
- Actively follow up with SMEs to resolve data discrepancies.
Requirements
- Bachelor’s Degree or equivalent.
- Regulatory Affairs degree desirable.
- Some experience in global/multi-national pharmaceutical environment.
- Experience in Labeling and/or regulatory affairs role preferred.
- Ability to work independently and manage multiple priorities at one time.
- Demonstrated excellence in project management/project coordination.
- Clear and adaptive verbal and written communication skills.
- Strong facilitation, project management and coordination skills.
Benefits
- Health insurance
- Retirement plans
- Professional development
- Flexible working arrangements
Job title
Job type
Experience level
Salary
Not specified
Degree requirement
Location requirements
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