Valeant Pharmaceuticals

Manager Regulatory Affairs

US-NY-Rochester
Job ID
8462
Category
R&D
Pos. Type
Full Time

Overview

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.

 

Responsibilities

- 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.

Qualifications

TECHNICAL COMPETENCIES:
- Knowledge of pharmaceutical industry regulatory affairs discipline throughout the product life-cycle including Development, Commercialization, and Operations.
- Knowledge of FDA regulations relating to submissions and regulatory approval of drug products.
- Knowledge of pharmaceutical industry product labeling processes for review and obtaining regulatory approvals.
- Strong technology skills and abilities, especially with Microsoft Office programs and web-based programs.
- Ability to critically and efficiently review detailed information to support a labeling revision.
- Strong technical knowledge of drug listing and SPL.

PROFESSIONAL COMPETENCIES:
- Demonstrated ability in analytical reasoning and critical thinking skills.
- Ability contribute and lead a team environment.
- Ability to understand and apply business drivers outside of Regulatory Affairs.
- Strong communication skills; both oral and written.
- Strong interpersonal skills with the ability to influence others in a positive and effective manner.
- Detail-oriented with the ability to proofread and check documents for accuracy and inconsistencies – able to do so quickly without sacrificing attention to detail.

- 4+ years relevant pharmaceutical industry and regulatory experience, 2 + years’ experience within pharmaceutical labeling, Bachelor’s degree or higher, Applied knowledge of FDA labeling requirements, Familiarity with XML concepts including structured product labels (SPLs) preferred.

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