Valeant Pharmaceuticals International, Inc. is a diverse and decentralized pharmaceutical company that is committed to focusing on our key stakeholders while delivering consistently high performance. Our values provide the overall direction for our company, and provide us with the tools necessary to rise to any challenge by leveraging our collective hard work and effort along with our unwavering competitive spirit. These values help us set goals based on our organization’s potential and what we hope it will become.
- Provide Regulatory support in the development, revision, review, and approval of labeling content for submission to FDA, as well as any post marketing labeling changes.
- Review new labeling for accuracy and for other regulatory requirements such as NDC codes, DEA requirements, Child-resistant text, foreign manufacturer information, etc.
- Liaise with Regulatory Affairs members and other cross-functional teams (e.g., supply chain, legal, medical, pharmacovigilance) to ensure the accuracy of all information included on the label or in the labeling.
- Support the review process and coordinate with other Regulatory functions for the submission, approval, and notification of new/revised labeling content.
- Develop and maintain tools/lists that support the coordination with other functions (e.g., Quality, Manufacturing) to make certain only agency approved labels are produced for appropriate products.
- Monitor changes to Reference Listed Drug (RLD) products.
- Support Regulatory Leads by creating labeling documents for FDA submissions.
- Maintain, catalog, and retain all labeling materials in accordance with company policies, procedures, and technologies.
- Complete electronic drug listing for applicable drugs in accordance with federal requirements and guidance documents.
Scope of Position: U.S. distributed product labeling.
Key Relationships: Internal business functions and external partners related to the development, execution, and implementation of regulated labeling.