Associate Director, Regulatory Labeling

Olema Oncology is a cancer medicines company dedicated to impacting breast cancer and beyond. Our lead program, palazestrant (OP-1250), is a differentiated oral medicine known as a complete estrogen receptor antagonist (CERAN) initially in development for metastatic breast cancer. Our pipeline also includes OP-3136, a potent, selective oral inhibitor of the KAT6 pathway. At Olema, we are building a focused team committed to our mission with intention and clarity. Working alongside a talented passionate group of leaders and advisors, we strive to create better medicines that aim to help patients feel better, longer. For more information, visit us at www.olema.com .

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 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:

Ideal Candidate Profile >>>

• 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).
• 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), Core Safety Information (CSI), United States Package Inserts (USPI), Summary of Product Characteristics (SmPC), and their associated Patient Labeling Documents to support b 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.
• Lead the development of Standard Operating Procedures (SOPs) and process improvements for labeling generation and maintenance.
• Represent Regulatory Affairs Labeling in project teams across 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. 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 and 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:

• 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.
• Experience developing and managing labeling content for at least one major submission (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.
  
  

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 $180,000 - $195,000 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.

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.

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

Additional Note/Fraud Alert: Olema will not conduct interviews via text message or messaging platforms and will not ask you to download anything as part of your interview. Though we use third party tools to help with advertising our jobs, please be vigilant in checking that the communication is in fact coming from Olema.