Manager, Global Labeling Compliance and Operations-Remote Eligible

The Global Labeling Team at Vertex is seeking a highly motivated Manager of Labeling Compliance and Operations - Rest of World (ROW), who understands global labeling. They will ensure labeling is compliant with regulatory requirements and global labeling processes, provide support for inspection readiness, oversee and support the management of regional product labeling, review and approve packaging artwork and liaise with critical labeling stakeholders in commercial and supply chain.

The right candidate will have an ability to develop strong matrixed working relationships and will be responsible for supporting the Regional Labeling Lead (RLL) in collaboration across the global regulatory affairs department and with cross-functional experts to develop global labeling strategies for marketed products. A pro-active individual, the Manager of Global Labeling Compliance and Operations - ROW will have an ability to lead, influence and work collaboratively.

Key Responsibilities:

• Product Operations
  • Support the Regional Labeling Lead (RLL) in the development and maintenance of regulatory labeling priorities and timelines for ROW markets.
  • Collaborate with artwork and other stakeholders to identify requirements and develop initial submission labeling artwork for new markets.
  • Management of the ROW packaging and labeling creation, review, endorsement through labeling governance and approval.
  • Author regulatory response documents for package component labeling responses in ROW countries.
  • Collaborate with artwork and supply chain stakeholders to plan and implement label changes.
  • Provide regulatory labeling impact assessments for ROW change control records.
  • Ownership of labeling deviations and CAPA's for ROW markets.
  • Support the Regional Labeling Lead (RLL) in the development of the regional product labeling as needed, and for the tracking and archiving of key documents.
  • Responsible for the process and communication of approved labeling to ROW markets to support HCPs.
  • Proofreading and departmental QC, as needed.
• Department Operations
  • Liaise with vendors to, as needed, to obtain support for ROW Labeling for services such as translations.
  • Manage departmental projects to pursue process operations excellence (includes associated SOP and WI development and maintenance).
• Compliance:
  • Accountable for oversight of compliance with global labeling processes and supporting associated regional labeling for inspection readiness. This includestracking of package component labeling updates and internal labeling content deviations as well as maintenance of controlled records.

This position will report to the Global Head of Regulatory Labeling Compliance and Operations, GRA.

Skills/Experience:

• Possesses a working knowledge of regulations, guidelines and precedents related to pharmaceutical product development and marketing, with focus in the area of product labeling and packaging
• Excellent planning, organizational, analytical, problem-solving, proofreading, and decision-making skills
• Experience leading process improvement projects
• Experience managing projects or coordinating multiple activities at once
• Ability to lead and motivate others
• Ability to drive projects to completion
• Ability to exercise sound judgment and operate with a high degree of independence regarding routine and non-routine assignments
• Possesses excellent written and verbal communication skills
• Strong computer skills, including a working familiarity with electronic document management systems for compliant maintenance and version control of submitted, approved and in-use labeling
• Experience with pharmaceutical labeling regulations in ROW markets, with a focus on Middle East, Asia, and Balkans (non-EU member countries) is desirable
• Experience in Quality Management Systems for change control, deviation and CAPA management.
• Experience in use of RIM management system is desirable
• Experience with label tracking tools is desirable

Minimum Requirements:

• Bachelors degree (preferably in a life sciences field) with preference to higher degree.
• Extensive experience in the pharmaceutical industry, in one or more of the following areas: Regulatory project management, Regulatory labeling development, promotional product communications and/or review for prescription pharmaceuticals or similarly regulated industry required.

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