Senior Director of Regulatory Labeling, Advertisements and Promotions

Role Summary

Senior Director, Regulatory Labeling, Advertisements and Promotions leads the development of labeling for clinical supplies and commercial labeling materials for Olema products. The role oversees regulatory-compliance advertising and promotional materials and requires strong knowledge of labeling and promotional regulations. This position collaborates with Regulatory Affairs, Clinical Development, Commercial, Legal, CS, QA, CMC, and external vendors to ensure quality controls are integrated into labeling and promotional activities.

Responsibilities

• 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.
• Oversee 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.
• Provide leadership and guidance to cross-functional labeling teams and align on the labeling content.
• Oversee and manage the commercial label and promotional materials life cycles and associated systems.
• Develop and implement harmonized labeling processes for developing new product labels, promotional materials, and associated life-cycle activities.
• Lead the development of Standard Operating Procedures (SOPs) and process improvements for labeling and promotional materials generation and maintenance.
• Represent Olema with the FDA/OPDP as required and manage regulatory interactions and oversee all labeling and promotional material submissions to Health Authorities.
• Represent Regulatory Affairs Labeling, Advertisement and Promotions on project teams across products and ensure standard implementation of regulations across development products.
• Provide regulatory leadership on cross-functional Promotional Review Committee(s) to ensure development of regulatory compliant advertisement and promotional materials.
• Oversee labeling and promotional material activities managed by external vendors, ensuring coordination and timely delivery.
• As a key leader in the Regulatory Affairs organization, shape the team’s structure and strategy to ensure long-term success by building and mentoring Regulatory labeling, advertisement and Promotions team within the department and mentoring junior staff.

Qualifications

• Knowledge: Bachelor’s degree is required; a bachelor's degree in a scientific field or a master's degree strongly preferred. Understands Regulatory, Quality and Supply Chain aspects of clinical labeling and impact of non-compliance. Knowledge of applicable regulations and standards affecting labeling and packaging of investigational drugs globally. Strong knowledge of FDA promotional material regulations for oncology products. Expert knowledge of evidentiary standards supporting product claims. Strong knowledge of FDA and EMA product labeling requirements, regulations, and guidelines (USPI experience required; SmPC experience preferred). Extensive knowledge and experience with development of promotional materials in accordance with regulations.
• Experience: 12+ years of experience in clinical research, biotech, and/or pharmaceutical company, with 10+ years of Regulatory Affairs experience within clinical research or pharmaceutical. 5–7 years of leadership experience. Experience in regulatory affairs and quality assurance and deep knowledge of global regulatory labeling and promotional materials development and maintenance. Experience working with ICH Health Authorities. Experience with developing and managing labeling and promotional content for major submissions (e.g., NDA/BLA), through negotiations and approval. 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 understanding of clinical study designs and GMP documentation. Demonstrated oncology product label, advertisement/promotional materials expertise.
• Attributes: Strong communication skills and the ability to effectively build productive internal and external working relationships. Strong oral and written communication and negotiation skills. 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. Excellent attention to detail, strong critical thinking, problem solving, and managing change.

Education

• Bachelor’s degree required; degree in scientific field; Master’s strongly preferred.

Additional Requirements

• Location: Cambridge or San Francisco office.
• Travel: Up to 20% travel.