Executive Director, Regulatory Labeling

  • Company: Amgen
  • Posted: January 12, 2017
  • Reference ID: R-30292
This role provides corporate oversight and impact assessment for labeling development and maintenance. Leads Global Labeling Operations and Compliance group; Provides tactical guidance for drug product labeling development and maintenance to Senior Management Team.
Key responsibilities will include:
Leading cross-functional teams (LWG/ELB/SMT) in the development and maintenance of drug product labeling
Provides labeling strategies and guidance to facilitate development/maintenance of safe and commercially viable drug product labeling to facilitate best possible patient and company outcomes
Establishes required participants, accountabilities and timelines for labeling decisions, ensures stakeholder awareness of and adherence to, corporate labeling processes
Troubleshoots and solves any conflicts or issues on the critical path to reaching a labeling decision
Facilitates consensus among labeling teams and secures proper sign-off on labeling decisions
Solicits and ensures corporate approvals for the implementation of labeling changes are received and maintains record of labeling decisions and approvals (LPT), notifies appropriate corporate stakeholders of approved labeling changes and assures timely dissemination of information
Responsible for drafting, editing, proofing and creating final corporate approved product labeling documents in corporate labeling document management system (EPIC)
Provides Regulatory Submissions (link/virtual document) of final approved labeling documents (Word and Structured Product Labeling (SPL) formatted labels) for agency submission
Leads cross-functional team discussion on the process for implementation of FDA approved product labeling (US prescribing and patient information and Dear Health Care Provider (DHCP) Letters)
Enters editorial corrections of relevant labeling changes in the Bin and Corrigendum System, in collaboration with Global Labeling Operations (GLO). GLO utilizes information for Annual Report of Minor Changes
Supports corporate audits of product labeling processes and documents, provides requested materials, assists in interpretation of variation/deviations and highlights for GLOC discussion. Makes first pass assessment as to deviation/variation potential impact and required follow-up
Creates and maintains cumulative annotated labeling history documents for assigned products in corporate document management system (EPIC) Label History folder
Data entry and tracking of all labeling decisions/approvals into corporate Label Process Tracker (LPT); including tracking of labeling submissions to health authority; health authority decisions and notifications
Maintains external Label Process Tracker (LPT) logs related to deviations to product CDS, SOP 001170, and SOP 00691. Tracks and monitors PSRM Timeline Extensions for US RRR in SICMS
Ensures continuity in labeling lifecycle and stakeholder contribution from development Core Data Sheet (dCDS) to CDS to Regional Prescribing Information
Ensures that Core Data Sheets and regional labels provide essential information for the safe and effective use of the product(s) and are accurate and current
Develops and executes product labeling strategies that are aligned with global regulatory requirements/standards and corporate strategy
Collaborates with regional affiliates in the development and maintenance of global drug product labeling
Analyzes various regulatory and labeling alternatives for drug product labeling and recommends of alternatives to facilitate best possible patient and company outcomes
Maintains awareness of regulatory legislation pertaining to labeling and assesses and communicates its impact on the business and products of the company
Periodically reviews drug product RPI labeling for assigned products. Ensures CDS updates are implemented regionally in accordance with established corporate timelines and regulatory requirements / standards
Independently creates and maintains competitive labeling comparisons, proprietary regional labeling comparisons and precedent searches. Actively assesses impact of proposed labeling changes in relation to competitors
Contributes to improvements of new and current labeling processes to improve efficiency, productivity and quality, standards development, and metrics
Assist corporate training on regulatory affairs and contribute to the design and content development of department training programs
Sponsors internal and external (cross-functional) special projects
Advocates and actively supports regulatory/safety compliance
Owns and ensures compliance with Global Labeling SOPs and BPs
Approves all drug labeling and escalates labeling issues at own discretion
Develops and implements Global Labeling strategies to proactively address changes in regulatory environment affecting labeling
Partners closely with TA leads to develop and manage regulatory labeling strategies to facilitate product development and global submissions
Ensures that agreed global labeling strategies are efficiently implemented during drug product development and life-cycle management
Ensures that global labeling strategies are maintained in-line with changing regulatory and business needs
Participates in the development of internal and external strategies to proactively influence legislation/guidelines with impact on labeling
Contributes to regulatory affairs process improvement though development of scalable and responsive SOPs and BPs for global product labeling
Accountable for disseminating and explaining corporate and departmental information to staff and ensuring understanding and adherence to changes
Contributes through strategic management of subordinate managers and direction of major discipline or operation within Amgen, even though does not directly supervise large numbers of staff
Doctorate degree and 6 years of Labeling, Regulatory and/or Pharmacovigilance experience
Master's degree and 10 years of Labeling, Regulatory and/or Pharmacovigilance experience
Bachelor's degree and 12 years of Labeling, Regulatory and/or Pharmacovigilance experience
6 years of managerial experience directly managing people and/or leadership experience leading teams, projects, programs or directing the allocation of resources
Experience in the pharmaceutical, biotechnology or device industry in a Labeling, Regulatory, or Safety capacity
Proficiency with drug development, commercialization, and legal/compliance issues with relation to Labeling
Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.

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