Senior Regulatory Affairs Consultant leading labeling strategies within Global Regulatory Affairs for a biotech company. Ensuring alignment with labeling requirements and collaborating with various stakeholders.
Responsibilities
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
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