Director, Regulatory Affairs - Labeling

About the Role >>> Director, Regulatory Labeling 

As the Director, Regulatory Labeling, reporting to the Vice President, Regulatory Affairs and Quality Assurance you will lead the development of labeling for clinical supplies as well as development of 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. This role will work closely internally with Regulatory Affairs, Clinical Development, Clinical Supply (CS), Quality Assurance (QA), and the CMC teams as well as external vendors (clinical research / development and manufacturing organizations) to ensure appropriate quality control checks are proceduralized and implemented for all labeling activities. 

This role is based out of our Cambridge or San Francisco office and will require 10% travel. 

Your work will primarily encompass:  

• Oversee the prioritization, development, revision and approval of clinical supply labeling (e.g., active, placebos and standard of care drugs) in various countries to support Olema’s clinical pipeline 
• 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
• Develop and implement harmonized labeling processes for developing new product labels and associated life-cycle activities 
• Lead the development of Standard Operating Procedures (SOPs) and process improvements for labeling generation and maintenance 
• Create and maintain labeling project tracking tools and dashboards to monitor all labeling change deliverables across assigned projects and sites
• Oversight and accountability for labeling activities managed by external vendors, ensuring coordination and timely delivery
• Develop and maintain labeling documents including Company Core Data Sheets (CCDS), Structured Product Labeling (SPL), Core Safety Information (CSI), United States Package Inserts (USPI), Summary of Product Characteristics (SmPC), and their associated Patient Labeling Documents to support initial Marketing Authorization and updates for new indications, efficacy data, product quality changes and safety related information topics
• Present to cross-functional and executive level management to obtain endorsement, as appropriate, for the proposed labeling text
• Supports responses to Health Authority queries related to labeling
• Create and maintain artwork for critical Regulatory functions: prepare labeling mock-ups for Health Authority submissions, manage expedited artwork approval process for US and ex-US market product launches
• Design, implement and maintain document tracking, history, versioning for labeling documents 
• Represent Regulatory Affairs Labeling in project teams across products and ensure standard implementation of regulations across development products

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; bachelor's degree or master's degree in a scientific field 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)
• Strong knowledge of FDA and EMA product labeling requirements, regulations, and guidelines (USPI and EU SmPC experience required)
• Strong collaboration, presentation, communication, interpersonal, and leadership skills

Experience: 

• 10+ years of experience working in clinical research, biotech, and/or pharmaceutical company, with 8+ years of Regulatory Affairs experience within clinical research or pharmaceutical
• Proven 3-5 years in a leadership role
• Experience in regulatory affairs and quality assurance and deep knowledge of global regulatory labeling development and maintenance
• Experience working with ICH Health Authorities
• Experience with developing and managing labeling content for for major submissions (e.g., NDA/BLA), through negotiations and approval preferred
• 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. AD-Promo experience is preferred
• Oncology product label development is required

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 adept at managing change

The base pay range for this position is expected to be $230,000 - $245,000 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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