Regulatory Labeling Manager

About the role

The Regulatory Labeling Manager – Lifecycle Products is responsible for developing, maintaining, and overseeing labeling content for mature pharmaceutical products. This includes authoring and updating labeling documents in response to safety updates, regulatory requirements, and internal assessments.

Key responsibilities

• Plan and lead labeling updates driven by safety changes, regulatory commitments, and periodic reviews.
• Author and revise labeling documents such as CCDSs, USPI, EU SmPC, and ROW labels for lifecycle products.
• Support labeling governance activities, attend meetings, record minutes, and ensure approvals are obtained.
• Ensure labeling content complies with FDA, EMA, ICH, and internal standards.
• Collaborate with cross‑functional teams (Safety, Medical, Legal, Regulatory Strategy) to gather input and align on labeling changes.
• Support responses to health authority queries and partner with document specialists for submission‑ready formatting.

Required profile

• Typically 2+ years of experience in the biotechnology industry, preferably in Regulatory Affairs or Regulatory Labeling.
• Minimum Bachelor’s degree in a Science or Business‑related field.
• Experience supporting labeling negotiations with health authorities and interpreting safety data.

Required skills

• Strong understanding of global labeling regulations (FDA, EMA, ICH).
• Proficiency in Microsoft Word and document management systems such as Veeva Vault.
• Experience with label tracking systems (e.g., Intagras, Veeva Labeling).
• Familiarity with structured content authoring tools or XML‑based labeling systems and eCTD submissions.