Regulatory Labeling Project Coordinator - Senior
About this role
Company Description
Job Description
Description:
- Responsible for the coordination of new labeling implementation with Materials Management and Supply Chain Planners at multiple packaging sites worldwide.
- Allocates workload to ensure availability of required artwork for the full product range in compliance with new product approvals and existing product variation approval deadlines.
- Liaises with International and local Regulatory colleagues to obtain correct text, negotiate timelines and ensure that all requirements have been met.
- Contributes to the completion of operational excellence projects where prior precedents may not be set and outcomes require executing without prior experience.
- Manages complex workflows in an electronic labeling management system.
- Recommends improvements and develops systems/policies to enhance labeling operations.
- Authors standard operating procedures, guidelines and work instructions.
- Collaborates with team members to meet departmental goals and objectives.
- Completes labeling artwork updates as assigned.
Knowledge, Experience and Skills:
- Highly capable at directing and coordinating project work.
- Strong verbal, technical writing and interpersonal skills.
- Proficient in Microsoft Office applications.
- Knowledge of FDA and cGMP standards as well as regulatory guidance documents.
- Prior experience in pharmaceutical or other regulated industry is preferred.
- Familiarity with artwork production and graphic design software a bonus.
- 6+ years of relevant experience and a BS or BA.
- 4+ years of relevant experience and a MS.
Qualifications
Additional Information
All your information will be kept confidential according to EEO guidelines.
Frequently Asked Questions
Is the salary disclosed for the Regulatory Labeling Project Coordinator - Senior position at integratedresourcesinc?
The salary for this Regulatory Labeling Project Coordinator - Senior role at integratedresourcesinc is not publicly listed. Click "Apply Now" to learn more about the compensation package on their official careers page.
Where is the Regulatory Labeling Project Coordinator - Senior position at integratedresourcesinc located?
This Regulatory Labeling Project Coordinator - Senior role at integratedresourcesinc is based in CA, Foster City, Foster City, CA, United States, us. The position is listed as on-site or hybrid. Check the full job description or apply directly to confirm the work arrangement.
Is the Regulatory Labeling Project Coordinator - Senior role at integratedresourcesinc full-time or part-time?
This is listed as a Contract position. It is posted as a Regulatory Labeling Project Coordinator - Senior role at integratedresourcesinc.
How do I apply for the Regulatory Labeling Project Coordinator - Senior position at integratedresourcesinc?
Click the "Apply Now" button on this page. You will be redirected to integratedresourcesinc's official application portal hosted on smartrecruiters where you can submit your application directly.
When was the Regulatory Labeling Project Coordinator - Senior job at integratedresourcesinc posted?
This Regulatory Labeling Project Coordinator - Senior position at integratedresourcesinc was posted on Aug 30, 2017. Apply as soon as possible — early applications are often reviewed first.
Regulatory Labeling Project Coordinator - Senior
integratedresourcesinc
You'll be redirected to integratedresourcesinc's official application page on SmartRecruiters.