Responsible for Export Zone developing and implementing strategies for international markets in the wine sector. Collaborating with various teams and overseeing sales operations across Europe and North America.
About the role
- HUB Labeling Manager responsible for preparation and updating of labeling documents for national products. Act as SME on regulatory labeling and collaborate globally at Pfizer.
Responsibilities
- Responsible for preparation of LPDs, associated LLDs and PLDs for nationally registered products
- Updating the 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
- Participate in the sharing of intelligence in collaboration with other Hub Labeling Managers
- Serve as an SME for the use and development of current and new global tools, technologies and processes to support label development, submission and approval
- Maintain system management for labeling activities including Global Document Management System (GDMS) and Pfizer approved labeling tracking system
- Monitor system data integrity and quality checks
- Utilize regulatory knowledge to produce non-complex LPDs, LLDs and PLDs
- Produce labeling-related documentation for submission to HAs
- Perform QC check of other colleagues’ work
- Identify incremental improvements to labeling-related processes and systems
- Support provision of other deliverables within the scope of ILG responsibilities
- Work on projects involving the use of current and new global tools, technology and processes to support label development, submission and approval
- Assist with labeling data analysis
- Create or enhance SharePoint web pages
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
- Ability to understand, assess and manage the regulatory implications of product strategy with regard to the product label
- Knowledge of global/regional regulatory guidelines and requirements in addition to knowledge of Clinical Variations is important
- Ability to interpret and apply regional/local regulatory guidance around labeling and associated supportive documentation, both in the pre-approval and post approval stages preferred
- Demonstrated project management, attention to detail and problem-solving skills
- Proven strength in logical, analytical and writing ability essential
Benefits
- Health insurance
- 401(k) matching
- Flexible work hours
- Paid time off
- Remote work options
Job title
Job type
Experience level
Salary
Not specified
Degree requirement
Location requirements
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