Regulatory Labeling Manager (Sponsor Dedicated)

About the role

As a Sponsor Dedicated Regulatory Labeling Manager you will support the preparation and negotiation of product labeling with health authorities, ensuring safety data is accurately reflected and regulatory submissions are compliant.

Key responsibilities

• Lead labeling negotiations with health authorities and respond to queries.
• Interpret safety data and assess its impact on product labeling.
• Utilize structured content authoring tools and XML‑based labeling systems to create labeling content.
• Prepare labeling components for electronic Common Technical Document (eCTD) submissions.
• Collaborate with cross‑functional teams to align labeling strategy with regulatory requirements.

Required profile

• Minimum 2 years of experience in the biotechnology industry, preferably in Regulatory Affairs or Regulatory Labeling.
• Bachelor’s degree in a scientific or business‑related field.
• Experience supporting labeling negotiations with health authorities.
• Knowledge of safety data interpretation and its influence on labeling.

Required skills

• Structured content authoring tools
• XML‑based labeling systems
• eCTD submission preparation

What we offer

• Career development and progression opportunities.
• Supportive line management and technical/therapeutic training.
• Peer recognition and total rewards program.
• Inclusive culture that encourages authenticity.