Associate Director, Global Labeling Strategy

Discover International

Cambridge (MA)

On-site

USD 150,000 - 230,000

Full time

3 days ago

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Job summary

Discover International is seeking a Global Regulatory Labeling Strategy Lead (Associate Director) to guide strategic labeling and ensure regulatory compliance for plasma-derived therapies. You will influence internal stakeholders across Clinical, Pharmacovigilance, Legal, Scientific and Commercial teams to support labeling for drug and device products.

You will drive CCDS, USPI and regional labeling, align with Health Authority expectations, and lead global labeling teams to optimize patient

Qualifications

Requires deep knowledge of regulatory labeling requirements for drug and device products.
Experience leading labeling strategy development and lifecycle management.
Proven ability to collaborate with clinical, pharmacovigilance, legal and commercial teams.

Responsibilities

Lead global labeling strategy for PDT BU across US, EU and other markets.
Develop and implement innovative labeling strategies to support product development and commercialization.
Oversee CCDS, USPI and EU SmPC labeling processes and governance.
Provide guidance on regulatory labeling trends, templates, and Health Authority expectations.
Mentor and lead cross-functional labeling teams and projects.