Associate Director, Regulatory Labeling

About the Role >>> Associate Director, Regulatory Labeling 

As the Associate Director, Regulatory Labeling, reporting to the Senior Director, Regulatory Affairs CMC, you will lead the development of labeling for clinical supplies. As a regulatory labeling lead, you will oversee the prioritization, creation, review, approval, and maintenance of clinical labels. This role requires a solid understanding of global labeling requirements, a basic understanding of labeling platforms, and print production processes to effectively manage end-to-end label implementation. This role will work closely internally with the Clinical supply (CS), the quality assurance (QA), and the CMC teams and external (clinical research organization) to ensure appropriate quality control checks are proceduralized and implemented for all labeling activities.  

This role will be based out of our San Francisco, CA or Cambridge, MA office and will require 15% travel. 

Your work will primarily encompass: 

• Oversee the prioritization, development, revision and approval of clinical supply labeling in various countries  
• Serve as a strategic cross-functional partner working closely with the CMO/CRO labeling specialists, cross-functional project teams including Quality, Regulatory, Clinical Supply and CMC teams 
• Create and maintain labeling project tracking tools and dashboards to monitor all labeling change deliverables across assigned projects and sites 
• Coordinate and support labeling production implementation processes with manufacturing sites and vendors for various clinical studies 
• Own labeling development and approval activities specific to clinical supplies (active, placebos and standard of care drugs)

Ideal Candidate Profile >>>  

A love of challenging, important work. We are a pragmatic team, driven to imagine and develop meaningful therapies for improving lives. All employees within our company play a unique and crucial role in our success, both in accomplishing our mission and building a positive company culture. As such, we are looking for someone with the right combination of knowledge, experience, and attributes for this role. 

Knowledge: 

• Bachelor’s degree is required. A bachelor's degree in a scientific field or a master's degree is preferred
• Understands Regulatory, Quality and Supply Chain aspects of labeling and impact of non-compliance
• Knowledge of applicable regulations and standards affecting labeling Packaging of investigational drugs globally
• Clinical Supply Packaging and/or labelling and/or Distribution with external vendors (e.g. technical, process, plan or system)

Experience: 

• 8+ years of experience working in clinical research, biotech, and/or pharmaceutical company, with 5+ years of Regulatory Affairs experience within clinical research or pharmaceutical
• Experience in regulatory affairs and quality assurance and working knowledge of global regulatory labeling development and maintenance
• Demonstrated ability to work cross-functionally to develop project plans; proactively identify risks; develop risk mitigation strategies; communicate project team decisions and project status
• Ability to interact successfully in a diverse global environment and with senior level 
• management to effectively influence and manage change
• Proven general understanding of clinical study designs and Global Manufacturing Practices (GMP) documentation

Attributes: 

• Strong communication skills and the ability to effectively build productive internal and external working relationships
• Strong organizational, project management, and time management skills 
• Ability to independently execute day-to-day responsibilities
• Ability to independently exercise judgement in developing methods, techniques, and evaluation criteria for obtaining results in a fast-paced environment consisting of internal and external team members
• Excellent attention to detail, strong critical thinking, problem solving, and managing change

The base pay range for this position is expected to be $185,000 - $200,000 annually, however the base pay offered may vary depending on location, market, job related knowledge, skills and capabilities, and experience. The total compensation package for this position also includes equity, bonus, and benefits. 

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