Regulatory Affairs Consultant – Global Labeling Lead

ComplianceComplianceFull TimeRemoteSeniorTeam 10,001+Since 1983H1B SponsorCompany SiteLinkedIn

Location

United States

Posted

44 days ago

Salary

Not specified

Seniority

Senior

Bachelor Degree6 yrs expEnglish

Job Description

• Drive the labeling development and strategy, in-line with overall global strategy. • Provide labeling expertise for Company Core Data Sheet (CCDS) and local labeling (USPI, SmPC and other). • Evaluate and communicate strategies and anticipate risks associated with labeling content and timelines. • Lead or contribute to cross-functional teams to align the development and maintenance of global labeling for assigned compounds. • Partner with Global Regulatory Affairs to ensure all labeling is aligned with product global strategy. • Support global Health Authority interaction strategy regarding all aspects of labeling. • Collaborate with global colleagues and partners as needed. • Develop clear communications for senior management and labeling stakeholders.

Job Requirements

  • BSc or advanced scientific degree (MSc, PhD or PharmD) preferred.
  • 6-8 years of relevant pharmaceutical Labeling/Regulatory experience.
  • Thorough understanding of scientific principles and regulatory systems, relevant to drug development.
  • Experience writing CCDS and local labeling documents for new products.
  • Solid understanding and practical knowledge of labeling regulatory requirements, regulations and guidance required.
  • Ability to prioritize and manage multiple high to medium complex projects simultaneously.
  • Strong attention to detail.
  • Preference for experience with IT systems; knowledge of Regulatory Information Management System (RIMS) and electronic document management system (EDMS); proficiency in MS Office suite.

Benefits

  • Health insurance
  • Retirement plans
  • Paid time off
  • Flexible work arrangements
  • Professional development

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