Hybrid Senior Regulatory Affairs Consultant – Labelling Strategy

Posted 2 hours ago

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About the role

  • 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
  • Effective communication skills
  • Attention to detail
  • Fluency in English (verbal and written)

Benefits

  • Health insurance
  • Flexible working arrangements

Job title

Senior Regulatory Affairs Consultant – Labelling Strategy

Job type

Experience level

Senior

Salary

Not specified

Degree requirement

Bachelor's Degree

Location requirements

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