Senior Director of Regulatory Labeling, Advertisements and Promotions

Olema Oncology is dedicated to developing better medicines for breast cancer and beyond. Our scientific breakthroughs are accelerated through the ways in which we fearlessly support, motivate, and challenge one another. Let’s make a profound impact together for our patients, for your career, for what’s beyond.

About the Role

As the Senior Director, Regulatory Labeling, Advertisement and Promotions reporting to the Senior Vice President, Regulatory Affairs you will lead the development of labeling for clinical supplies as well as development of commercial labeling materials for Olema products. This role will also oversee the development of regulatory compliance advertisements and promotional materials for assigned Olema products. This role requires a solid understanding of regulatory requirements for labeling advertisement and promotional materials. The role will work closely internally with Regulatory Affairs, Clinical Development, Commercial, Legal, Clinical Supply (CS), Quality Assurance (QA), and the CMC teams as well as external vendors to ensure appropriate quality control checks are proceduralized and implemented for all labeling and promotional activities. This role is based out of our Cambridge or San Francisco office and will require up to 20% travel.

Responsibilities and Leadership

• 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 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.
• 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 the regulatory interactions and oversee all the 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, you will 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 mentor junior staff.

Knowledge

• Bachelor’s degree is required. A bachelor’s degree in a scientific field or a master’s degree is 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 and understanding 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 working in clinical research, biotech, and/or pharmaceutical company, with 10+ years of Regulatory Affairs experience within clinical research or pharmaceutical. Proven 5‑7 years of leadership role.
• 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 preferred required.
• 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.
• Demonstrated Oncology product label, advertisement/promotional materials expertise is required.

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 consisting of internal and external team members.
• Excellent attention to detail, strong critical thinking, problem solving, and managing change.

Base Pay

The base pay range for this position is expected to be $260,000 - $290,000 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.

Seniority level

Director

Employment type

Full‑time

Job function

Research, Science, and Manufacturing

Industries

Biotechnology Research and Pharmaceutical Manufacturing

Important Information

We provide equal opportunity to all employees and applicants for employment and believe that great ideas and discoveries come from a mix of expertise, background, and experience. Olema is building a culture where the value of difference is celebrated. We offer a competitive compensation and benefits package, seeking to provide an open, flexible, and friendly work environment to empower employees and provide them with a platform to develop their long‑term careers. A Summary of Benefits is available for all applicants.

Fraud Alert: Please note that Olema’s official email addresses end in @olema.com. Our official corporate website is olev.com; our careers page is olev.com/careers; our LinkedIn page is linkedin.com/company/olema-oncology . Communication from any other variant is fraudulent. Olema does not conduct interviews via text message/messaging platforms, will not ask you to download anything as part of your interview, will never request any form of payment, provide upfront payments of any kind, and does not make job offers without an in‑person interview.

Please note: Olema doesn’t accept agency resumes and is not responsible for any fees related to unsolicited resumes. Thank you.