Manager (f/m/x) developing technical and commercial offers for environmentally sustainable medium - voltage switchgear at Nuventura in Berlin. Collaborating with global sales teams and representing at trade fairs.
About the role
- HUB Labeling Manager at Pfizer, responsible for regulatory labeling documentation for national markets. Collaborating on global tools and maintaining data integrity in labeling processes.
Responsibilities
- Responsible for preparation of LPDs, associated LLDs and PLDs for nationally registered products
- Update labeling documents on a timely basis according to internal SOPs and external regulatory requirements
- Act as a Subject Matter Expert (SME) on local, regional and multi-country regulatory labeling requirements
- Serve as an SME for the use and development of current and new global tools, technologies and processes to support label development
- Maintains system management for labeling activities including Global Document Management System (GDMS) and Pfizer approved labeling tracking system
- Monitors system data integrity and quality checks
- Produces labeling documents for submission to HAs such as track change versions, annotated labels, comparison tables
- Performs QC check of other colleagues’ work
- Identifies incremental improvements to labeling-related processes and systems
- Supports provision of other deliverables within the scope of ILG responsibilities e.g. readability testing
- Works on projects involving the use of current and new global tools, technology and processes to support label development
Requirements
- Life sciences, pharmacy graduate or equivalent; or equivalent relevant professional experience
- Fluency in English language important however multi-language skills are advantageous
- Experience working with structured data, such as in enterprise databases, MS Excel, MS SharePoint and/or MS Access
- Knowledge of key regulatory and labeling principles and local regulations
- ‘Hands on’ registration experience associated with development, maintenance and commercialization activities within Regulatory Affairs
- Demonstrated ability to develop strong and positive working relationships across multiple cultures and locations
- Demonstration of attention to detail and problem-solving skills
- Proven technical aptitude and ability to quickly learn new software
- Proven strength in logical, analytical and writing ability essential
Benefits
- Health insurance
- Retirement plans
- Paid time off
- Flexible work arrangements
- Professional development
- Disability inclusion
Job title
Job type
Experience level
Salary
Not specified
Degree requirement
Location requirements
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