Key skills
Communication
About this role
Role Overview
- 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