Global Labeling Operations Lead
Global Labeling Operations Lead
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Job Description
The Global Labeling Operations Lead is responsible for coordinating managing and executing activities related to the approval and maintenance of printed labeling components (e.g. packaging mockups patient information leaflets container labeling). The role will also support the Global Labeling and Regulatory Strategy teams with various operational labeling activities as well as help develop and/or improve internal processes.
This position will be within Global Regulatory Affairs (GRA) and will report to the Head of Global Labeling.
Key Responsibilities:
- Manage labeling and packaging artwork projects affecting multiple products to ensure timely delivery.
- Coordinate labeling artwork lifecycle management in collaboration with the Regulatory Strategy Leads and Labeling Operations Coordinators.
- Provide expertise to crossfunctional teams and external vendors regarding regulatory requirements for the development of printed labeling components.
- Review and approve mockups and artworks to ensure compliance and timely delivery of printready packaging and labeling documents.
- Coordinate EU labeling readability testing and translation activities with vendor and oversee affiliate review of EU SmPC translations during linguistic review.
- Manage EU SmPC master documents in the Veeva Regulatory Information Management (Veeva RIM) system during product labeling life cycle.
- Collaborate with Global Strategic Labeling Leads to support the delivery of submissionready EU and US labeling documents (e.g. EU QRD template formatting requirements quality control activities).
- Serve as a liaison to external vendor regarding the creation review and submission of US Structured Product Labeling (SPL) content.
- Support global labeling management improvement initiatives and participate in the development of SOPs Work Instructions and guidance documents.
Qualifications :
Education/Learning Experience/Work Experience
- 5 years of experience in Labeling Operations within the pharmaceutical industry.
- Experience in developing regulatory content for printed labeling components (e.g. carton and container) for EU (MAA/variations) and/or US (NDA/BLA) submissions; experience with additional regions/countries is a plus.
- Experience working in a global environment.
- Strong track record of leading projects and collaborating effectively in crossfunctional teams.
Skills/Knowledge/Languages
- Strong knowledge of EU and/or US labeling regulations and guidance.
- Proficiency in working with electronic document management systems (e.g. Veeva) as well as the MSOffice Suite and Adobe Acrobat.
- Fluency in English additional language skills are a plus.
- Ability to think strategically communicate risks effectively and recommend appropriate courses of action.
- Strong attention to detail.
- Excellent communication and negotiation skills.
- Comfortable working across geographies and in a culturally diverse organization with extensive crossfunctional collaboration.
Personal Attributes
- Results driven and teamoriented attitude.
- Excellent organizational and time management skills.
- Handson approach and flexibility to succeed in a smallteam environment within a growing organization.
Remote Work :
Yes
Employment Type :
Fulltime
Employment Type
Remote
