Associate Director, Global RA Labeling Lead

Job Function:
Quality Consultant Lead

Location:

Cambridge, MA - Hybrid

USDM Life Sciences is a premier consulting company with 20+ years of experience assisting heavily regulated biotech, medical device, and pharmaceutical companies with their GxP technologies to accelerate growth. Our deep domain knowledge and technology expertise in life sciences business processes are what set us apart. From strategy to implementation and adoption, we have delivered thousands of GxP projects globally.

As part of the USDM team, you have the opportunity to work with cutting-edge technologies through our many partnerships with companies like Microsoft, Google, Oracle, Docu Sign, Box, and many more. From molecule to market, you will help connect technology, people, and data in new ways to generate real-time insights to improve business outcomes for USDM’s clients. Are you ready to make an impact and drive real digital transformation in life sciences?

Founded in Santa Barbara in 1999, USDM has grown to a progressive, global company with 300+ remote employees and offices throughout the US, Canada, and Germany.

The Global Regulatory Labeling Strategy Lead (Associate Director) for the Plasma-Derived Therapies Business Unit (PDT BU) is a senior role within Global Labeling, reporting to the Head of Global Labeling. Working with minimal oversight, this person provides regulatory expertise and strategic guidance on drug and device labeling to stakeholders across Clinical, Pharmacovigilance, Legal, Scientific, and Commercial teams, ensuring labeling strategy is integrated into broader regulatory submission and negotiation plans.

The role involves developing strategies for new and revised prescribing information and packaging by interpreting scientific, medical, and regulatory data, and serving as the go-to expert on labeling requirements, templates, tools, and Health Authority guidance.

Responsibilities

• Drives labeling strategy for the PDT BU via the development and lifecycle management of the CCDS, US, and EU labels.
• Formulates and implements innovative regulatory strategies for labeling development to support successful commercialization of developmental products and enhance opportunity for marketed products and global expansion.
• Prepares strategic labeling vision for early development programs and gains alignment from internal stakeholders.
• Draws on labeling precedent, Health Authority feedback, and guidance, to create innovative labeling strategies.
• Provides guidance on combination product/drug-device labeling.
• Interprets scientific and clinical data and leads development of labeling to optimize product potential and patient benefit-risk ratio.
• Introduces creative solutions for data presentation and gains consensus by labeling teams to meet the requirements of the Health Authorities
• Prepares backup strategies in support of labeling negotiations.
• Takes initiative in leading global labeling team and cross-functional projects.
• Leads CCDS, US, and EU Labeling Teams in the development and maintenance of labeling.
• Actively engages cross-functional labeling stakeholders to gain consensus on labeling strategy.
• Effectively identifies and resolves conflicts/issues to reach labeling decisions with minimal escalation to management for dispute resolution.
• Liaises with Regulatory Intelligence to maintain awareness of regulatory legislation pertaining to labeling and communicates the impact on the PDT BU products.
• Provides guidance to Regulatory affiliates as necessary in assessment of labeling changes to ensure timely implementation.

Dimensions and Aspects

• In close collaboration with Client R&D labeling function, oversees the direction, management and implementation of the labeling processes, templates, tools and systems to improve efficiency, productivity and quality and consistency across products and compliance with regulatory labeling guidance.
• Project manages new or updated labeling to ensure compliance with internal procedural or Health Authority submission timelines.
• Manages and facilitates review of CCDSs and regional labeling, as appropriate, via the Labeling Team and executive governance committees for PDT BU products.
• Prepares final proposed labeling for review by the Labeling Team and approval by the executive governance committees, as appropriate, prior to internal approval and/or submission to health authorities.
• Manages the preparation of submission-ready labeling components, consults with affiliates on…