A global, research driven pharmaceutical company in the Greater Boston Area (relocation assistance provided) is looking to hire for a Manager/Senior Manager of Regulatory Labeling.
The company is among the top 10 pharmaceutical companies in the U.S. and has a global presence in over 80 countries. Their primary focus is in oncology, gastroenterology, and neuroscience, having developed a significant amount of variety in their product catalog in order to promote stability in their business. It is an incredibly exciting time to join the organization, as they have recently acquired a fantastic location in the Greater Boston area and are looking to further build out their management team.
This Manager/Senior Manager of Regulatory Labeling will work with the company's Research and Development department, leading cross functional teams on the global regulatory labeling needs for the company's diverse portfolio of products. Acting as the regulatory expert this position focuses on ensuring global regulatory labeling requirements are met for specific products, as well as developing and implementing Company Core Data Sheets (CCDS).
In this role you will have the opportunity to work with one of the most exciting and innovative pharmaceutical companies. This organization prides themselves on utilizing their research to lead market trends, while still recognizing the needs of the consumers who rely on their therapeutic products.
QUALIFICATIONS
* 4+ years of pharmaceutical industry experience.
* 3+ years of labeling experience.
* Knowledge of global standards and regulations related to CCDS and Product Labeling.
* Prior experience in management position.
RESPONSIBILITIES
* Lead team develop and update CCDS and other key global labeling documents.
* Manage review and approval of CCDS and lead resolution of labeling issues.
* Provide guidance on regulatory labeling strategy and work cooperatively with various committees to improve upon these processes.
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Manager/Senior Manager of Global Labeling
- Location Boston
- Job type Permanent
- Salary Negotiable
- Discipline Regulatory
- Reference PR/241536_1588694595