Regulatory Affairs Sr Mgr (Global Labeling Lead)

Amgen - Thousand Oaks, CA

Posted 648 days ago
  • Experience
    Not Applicable
  • Job function
    Research, Science
  • Employment type
  • Industry
    Biotechnology, Pharmaceuticals
  • Employer job ID
  • Job ID

This is a preview of the Regulatory Affairs Sr Mgr (Global Labeling Lead) job at Amgen. To view the full job listing, join LinkedIn - its free!Join LinkedIn - its free!

About this job

Job description

The purpose of the Corporate Global Labeling group is to develop core labeling and provide quality drug product labels for health authority submissions that reflect regulatory standards and key stakeholder contributions and perspectives.

As part of this group, and under the supervision of a Global Labeling Director, the Global Labeling Lead facilitates the development of comprehensive drug product labels that are consistent with corporate strategy and competitive with other agents in the class. The Global Labeling Lead is responsible for the development, review, approval and maintenance of target and core product labeling documents for assigned products, and oversees the review and approval of regional labeling derived from core product labeling.

Job Summary:
Manages corporate labeling process for company’s core product labeling. Oversees review and approval process to ensure that regional prescribing information for assigned products is accurate, current and consistent with core labeling.
Provides tactical guidance to product labeling review teams regarding label development and maintenance.

Key Activities:
- Responsibility for the creation, development, and maintenance of primary labeling documents (Core Data Sheet, Core Patient Information Leaflet, Core Instructions for Use)
- Coordination of the review and approval of primary and derived labeling documents (regional prescribing/patient labeling) by the relevant labeling review committees (i.e., Labeling Working Group, Executive Labeling Board, and Senior Management Team)
- Ensures the dissemination of approved primary and derived labeling documents and supporting documentation to internal stakeholders
- Ensures quality of labeling deliverables i.e., alignment of labeling text with data and regional regulatory requirements, consistency between labeling documents
- Contributes to the continuous improvement of the end-to-end labeling process
- Contributes to global labeling strategy including the development of target product labeling

Basic Qualifications

- Doctorate degree and 2 years of directly related experience
- Master’s degree and 6 years of directly related experience
- Bachelor’s degree and 8 years of directly related experience
- Associate’s degree and 10 years of directly related experience
- High school diploma / GED and 12 years of directly related experience

Preferred Qualifications

- Pharmaceutical industry or health authority experience
- Product labeling/labeling experience
- Understanding of product development; biology and pharmacology relevant to the therapeutic area
- Business expert on global labeling process
- Knowledge of regulatory requirements and standards that govern drug product labeling and:
- Attention to detail
- Recognize and escalate issues
- Time Management
- Written and Verbal communications
- Planning
- Organizational Skills
- Problem Solving
- Managing and Measuring Work
- Presentation Skills
- Interpersonal Skills
- Process Management
- Meeting Facilitation and
- Negotiation Skills
- Microsoft suite – Outlook, Word, Excel, PowerPoint

About this company

Amgen discovers, develops, manufactures, and delivers innovative human therapeutics. A leader in biotechnology since 1980, Amgen was one of the first companies to realize the new science's promise by bringing safe, effective medicines from lab, to manufacturing plant, to patient. Amgen therapeutics have changed the practice of medicine, helping millions of people around the world in the fight against cancer, kidney disease, rheumatoid arthritis, bone disease, and other serious illnesses.

Amgen pioneered the development of novel products based on advances in recombinant DNA and molecular biology, and launched the biotechnology industry's first blockbuster medicines. Today, as a Fortune 500 company serving millions of patients, Amgen continues to be an entrepreneurial, science-driven enterprise dedicated to helping people fight serious illness.

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