Global Regulatory Labeling Strategy

Description:

Proclinical is seeking a Director, Global Regulatory Labeling Strategy for a growing, global immunology-focused biotechnology company based in the Greater Boston, MA area. This is a remote position available for candidates based on the East Coast USA.

As the Associate Director, you will lead the labeling development of one asset, supervise the Target Product Label initiative across the company’s portfolio, and contribute to the labeling strategy of other assets as needed.

Key Responsibilities:

• Lead the labeling development strategy in cross-functional teams, ensuring alignment with target product profile, competitor review, regulations, and development data, and present these strategies for governance endorsement.

• Create and maintain the target product profile for one asset from phase 2 until the registrational phase and for new indications of registered assets.

• Create and maintain the Core Company Data Sheet.

• Partner with the Labeling Operation Manager to develop and maintain the global labeling implementation plan.

• Support the US affiliate in the creation and maintenance of USPI.

• Coordinate global labeling impact assessments of health authority or internal queries related to local label updates in the post-marketing phase. This will involve working with a cross-functional team, the Labeling Working Group (LWG), and the Global Labeling Committee (GLC).

Skills & Requirements:

• Bachelor’s Degree (required).

• At least 5 years of experience in global labeling strategy, both development and post-marketing.

• Prior experience with biologic products, medical devices, and combined products.

• Strong understanding of the end-to-end labeling process and its interfaces between clinical development, medical affairs, pharmacovigilance, regulatory affairs, quality assurance, and supply chain to ensure compliance.

• Knowledge of US, EU, and Japanese labeling templates and the labeling sections of eCTD dossiers.

• Familiarity with health authority websites, particularly FDA and EMA, to retrieve labeling precedents and regulatory requirements.

• Proficiency in electronic tools such as Dr. Evidence/Doc Label, Adobe Acrobat Pro, Regulatory Information Management Systems, Electronic Document Management Systems (e.g., Veeva Vault), and tools for labeling quality control (Text Verification Tool).