Parexel

Regulatory Affairs Consultant – Labelling Strategy

Parexel

full-time

Posted on:

Location Type: Remote

Location: United Kingdom

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Job Level

SeniorLead

About the role

  • Act as a labeling strategist within Global Regulatory Affairs (GRA)
  • Drive the maintenance of the Company Core Data Sheet (CCDS), the US Prescribing Information (USPI) and the EU Summary of Product Characteristics (SmPC) for product portfolio
  • Ensure optimal alignment of the company position, labeling requirements, and commercial opportunities for a therapeutic area
  • Manage the exception process between the CCDS and the USPI and EU SmPC
  • Collaborate with relevant Subject Matter Experts and stakeholders
  • Ensure consistent communication to the Global Labeling Associates, regions and countries regarding updated CCDSs for assigned portfolio of products
  • Maintain compliance by leading the assessment and Global Labeling Committee review of proposed exceptions
  • Represent Global Labeling on respective product Global Regulatory Affairs Strategy Teams

Requirements

  • University degree in Life Sciences or related Pharmaceutical field
  • Minimum of 7 years of biotech/pharmaceutical industry experience, including 4 years of labeling/regulatory experience combined with other global responsibility
  • Knowledge and understanding of principles of regulatory relevant to drug development, global labeling, and post-marketing requirements
  • Demonstrated problem-solving ability; able to analyze risk and make appropriate recommendations/decisions
  • Effective communication skills to a variety of audiences, specifically related to the explanation of complex concepts, options and impact
  • Attention to detail, coupled with the ability to think strategically
  • Fluency in English (verbal and written)
Benefits
  • Health insurance
  • Professional development opportunities
  • Flexible working arrangements
Applicant Tracking System Keywords

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

Hard Skills & Tools
labeling strategyCompany Core Data Sheet (CCDS)US Prescribing Information (USPI)EU Summary of Product Characteristics (SmPC)regulatory compliancerisk analysisglobal labelingdrug developmentpost-marketing requirements
Soft Skills
problem-solvingeffective communicationattention to detailstrategic thinking