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Director, Regulatory Affairs - Labeling

Olema Oncology
Full-time
On-site
hybrid
$230,000 - $245,000 USD yearly
Other
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Director, Regulatory Affairs - Labeling

Company Name: Olema Oncology

Job Overview

The Director, Regulatory Labeling will lead the development of labeling for clinical supplies and commercial labeling materials for Olema products. This role requires a solid understanding of global labeling requirements, labeling platforms, and print production processes to effectively manage end-to-end label implementation.

Responsibilities

  • Overseeing the prioritization, development, revision, and approval of clinical supply labeling
  • Developing harmonized labeling processes
  • Leading the development of SOPs for labeling generation and maintenance