Director, EU Regulatory Strategy

Olema Oncology is a clinical-stage biopharmaceutical company committed to transforming the standard of care and improving outcomes for patients living with breast cancer and beyond. With our transformation into a fully integrated oncology company well underway, it’s an exciting time to be part of Team Olema. 

Our lead product candidate, palazestrant, is a novel, orally available complete estrogen receptor antagonist (CERAN) and selective estrogen receptor degrader (SERD) currently in two pivotal Phase 3 clinical trials. We expect top-line data from OPERA-01, our ongoing Phase 3 trial of palazestrant as a monotherapy in patients with second- or third-line ER+/HER2- metastatic breast cancer (MBC), in Q1 2027 which, if positive, could lead to our first potential approval and commercial launch in 2028. OPERA-02, our Phase 3 trial of palazestrant in combination with ribociblib in patients with frontline ER+/HER2- MBC, is enrolling patients. Together with its mechanism of action, pharmacokinetic properties, and the potential to demonstrate activity in both ESR1 wild-type and mutant tumors, palazestrant could transform the metastatic breast cancer treatment paradigm and provide access to a $15 billion global market opportunity. 

Our follow-on product candidate, OP-3136, is a potent KAT6 inhibitor with the potential to generate further value and meaningfully impact the metastatic breast cancer treatment landscape – particularly in combination with palazestrant. We recently presented encouraging Phase 1 monotherapy data from this program across multiple solid tumor types, are advancing patient enrollment in the ongoing combination arms in MBC, and expect to initiate a Phase 1 study of OP-3136 in combination with Bayer’s darolutamide in metastatic castration-resistant prostate cancer by the end of this year. 

Aspiring to transform the metastatic treatment paradigm is an ambitious endeavor that requires a resolute approach to developing better therapies and passionate colleagues dedicated to helping the patients we serve feel better, longer. Team Olema possesses a deep commitment to a shared purpose, the sustained pursuit of excellence, cultivating the courage required to advance our programs, the drive to succeed, and a collective capacity for adaptability through learning, growth, and evolution. We are a small group of nimble self-starters who bring consistency in our quest for the extraordinary every single day. 

If you’re ready to be part of a tenacious, courageous, agile, and growing team, join us in making a profound impact, together – for our patients, for your career, and for what’s beyond.  

About the Role >>> Senior Director, EU Regulatory Affairs 

Reporting to Senior Vice President, Regulatory Affairs, the Senior Director, EU Regulatory Affairs is responsible for leading the Regulatory Affairs function for Olema International, the Company's European subsidiary based in Ireland. Serving as the EU Authorized Representative, this individual provides strategic leadership for European regulatory activities supporting Olema's oncology programs and future commercialization efforts. The role is accountable for developing and executing EU regulatory strategies, leading interactions with the European Medicines Agency (EMA) and National Competent Authorities (NCAs), overseeing Clinical Trial Applications (CTAs) and CTIS activities, directing the submission and lifecycle management of the European Marketing Authorization Application (MAA), and ensuring ongoing regulatory compliance across the European Union. 

This role is based out of our Dublin, Ireland office and will require 15% - 20% International travel. 

Your work will primarily encompass: 

• Serve as the EU Authorized Representative for Olema International, ensuring compliance with applicable European Union pharmaceutical legislation and regulatory requirements
• Develop and execute EU regulatory strategies that support oncology clinical development, marketing authorization, commercial readiness, and product lifecycle management while aligning with global regulatory objectives
• Lead European regulatory support for clinical development activities, including CTIS submissions, Clinical Trial Applications (CTAs), substantial modifications, notifications, and lifecycle management
• Provide strategic leadership for the preparation, submission, approval, and lifecycle management of the European Marketing Authorization Application (MAA), partnering with Global Regulatory Affairs and cross-functional teams
• Serve as the primary regulatory liaison with the EMA, National Competent Authorities, Ethics Committees, and other European regulatory authorities
• Oversee all regulatory registrations, authorizations, licenses, and corporate regulatory obligations required to support Olema International
• Partner cross-functionally with Clinical Development, Clinical Operations, Quality, CMC, Pharmacovigilance, Legal, and Global Regulatory Affairs to ensure compliance and support business objectives
• Establish and maintain regulatory governance, processes, and documentation to ensure inspection readiness and operational excellence
• Represent Olema International with regulatory authorities, industry organizations, and external stakeholders

Ideal Candidate Profile >>> European Union Regulatory Representative

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. 

Education and Required Skills

• Advanced degree in Life Sciences, Pharmacy, Regulatory Science, or a related scientific discipline; advanced professional degree preferred
• Minimum of 15 years of progressive Regulatory Affairs experience within the biotechnology or pharmaceutical industry 
• 5+ years of direct leadership 
• Effective communicator with executive presence and influencing skills 
• Sound judgment and decision-making in complex, risk-based environments 
• Demonstrated expertise in European regulatory affairs, including the EU Clinical Trials Regulation (CTR), CTIS, EMA centralized procedures, and interactions with National Competent Authorities
• Significant experience leading or contributing to European Marketing Authorization Applications (MAAs) and post-approval lifecycle management 
• Experience serving as, or supporting, the regulatory responsibilities of an EU legal entity, including regulatory compliance and licensing activities
• Oncology regulatory experience is strongly preferred
• Experience leading successful European MAA submissions and approvals required
• Demonstrated ability to develop regulatory strategy, influence executive decision-making, and lead complex cross-functional initiatives in a global, matrixed organization

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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.

Fraud Alert:  We are aware of employment scams where individuals pose as representatives of Olema Oncology and make false use of our company name to defraud job seekers. To protect yourself, please note that Olema’s official email addresses end in @olema.com. Our official corporate website is olema.com; our careers page is olema.com/careers; our LinkedIn page is linkedin.com/company/olema-oncology. Please visit these links for official information from Olema. 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.