Parexel

Regulatory Affairs Consultant – Global Labeling Lead

Parexel

full-time

Posted on:

Location Type: Remote

Location: United States

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Job Level

Senior

About the role

  • 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.

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
Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools
labeling developmentlabeling expertiseCCDS writinglocal labeling documentsregulatory requirementsscientific principlesregulatory systemsdrug developmentproject managementattention to detail
Soft Skills
communicationcollaborationstrategic thinkingrisk assessmentcross-functional teamworkprioritizationproblem-solvingstakeholder engagementleadershiporganizational skills
Certifications
BScMScPhDPharmD