Senior Regulatory Affairs Consultant – Labelling Strategy
Parexel
full-time
Posted on:
Location Type: Hybrid
Location: Harrow • United Kingdom
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Job Level
About the role
- Act as the principal labeling strategist within Global Regulatory Affairs (GRA)
- Drive the development of Labeling strategies
- Ensure optimal alignment of the company position and labeling requirements
- Provide strategic input into the GRA Therapeutic Area Team from a labeling perspective
- Collaborate with various stakeholders and SMEs
- Lead the assessment and review of proposed exceptions
- Represent Global Labeling on product Global Regulatory Affairs Strategy Teams
Requirements
- University degree in Life Sciences or related Pharmaceutical field
- Minimum of 10 years of biotech/pharmaceutical industry experience
- 6 years of labeling/regulatory experience
- Strong scientific background and ability to understand and interpret scientific documents
- Demonstrated problem-solving ability
- Proficient regulatory and drug/biologic development knowledge
- Effective communication skills
- Attention to detail
- Fluency in English (verbal and written)
Benefits
- Health insurance
- 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 strategiesregulatory experiencedrug development knowledgebiologic development knowledgescientific document interpretation
Soft Skills
problem-solvingeffective communicationattention to detail