Regulatory Labeling Associate Director

Overview

You will drive ROW product labeling development and maintenance, ensuring governance and compliance across therapeutic areas. You’ll lead labeling strategy, negotiate with health authorities, and guide cross-functional teams to align with packaging labeling. Your work shapes how information is presented to patients and clinicians, impacting global labeling quality and regulatory outcomes. This role offers strategic influence within a biotech leader focused on patient care and regulatory excellence.

Responsibilities

• Develop, submit, negotiate and obtain approval for ROW labelling; ensure compliance with governance and business processes
• Lead Label Working Groups for ROW labeling topics and represent labeling at regional regulatory teams and governance meetings
• Coordinate with Labeling Operations to align with Package Component Labeling
• Develop labeling strategy and advise stakeholders on regulatory requirements; oversee health authority interactions including responses, negotiations and inspections

Key requirements

• Bachelor’s Degree
• Extensive experience in regulatory affairs in global labeling or related discipline
• Expert knowledge of global labeling requirements; experience with CCDS or reference label in local labeling
• Ability to plan, prioritize, lead and execute regulatory labeling projects; balance cost, risk, and timelines

• leadership
• stakeholder advisory and communication
• cross-functional collaboration
• Global regulatory labeling expertise
• CCDS or reference label usage
• Regulatory labeling governance

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