Senior Director, EU Regulatory Strategy

Olema Oncology; Leinster; On-site; EUR 160,000 - 200,000; Full time

Job summary

Olema Oncology, a clinical-stage biopharmaceutical company based in Ireland, is seeking a Senior Director, EU Regulatory Affairs to lead the European regulatory affairs function for Olema International from Dublin. The role drives EU regulatory strategies, interactions with EMA and NCAs, and lifecycle management for oncology programs, with 15%–20% travel planned.

The ideal candidate has 15+ years in regulatory affairs, strong leadership, and a deep understanding of EU CTR/CTIS processes, MAAs,

Qualifications

• Advanced degree in Life Sciences, Pharmacy, Regulatory Science, or a related scientific discipline.
• Minimum of 15 years of progressive Regulatory Affairs experience within the biotechnology or pharmaceutical industry.
• 5+ years of direct leadership.
• Experience with EU CTR, CTIS, EMA centralized procedures, and interactions with National Competent Authorities.
• Oncology regulatory experience strongly preferred and experience leading MAAs and post-approval lifecycle management.

Responsibilities

• Serve as EU Authorized Representative for Olema International and ensure compliance with EU pharmaceutical regulations.
• Develop and execute EU regulatory strategies to support oncology development and lifecycle management.
• Lead European regulatory support for clinical development activities, including CTIS submissions and CTAs.
• Oversee MAA submissions and lifecycle management in collaboration with Global Regulatory Affairs.
• Act as regulatory liaison with EMA, NCAs, Ethics Committees and other authorities.
• Manage regulatory registrations, licenses, and compliance across the EU.
• Collaborate cross-functionally with Clinical Development, Quality, CMC, Pharmacovigilance, Legal, and Global Regulatory Affairs.
• Establish regulatory governance and inspection readiness.
• Represent Olema International with regulatory authorities and industry groups.

Skills

Regulatory leadership

Strategic regulatory planning

Cross-functional collaboration

Influencing stakeholders

Regulatory strategy

Education

Advanced degree in Life Sciences/Regulatory Science/Pharmacy

15+ years regulatory affairs in biotech/pharma

5+ years of leadership

Job description

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. It’s an exciting time to be part of Team Olema , with our transfor mation into a fully integrated oncology company well underway , t op-line data from our lead program expected later this year , and our first potential commercial launch on the horizon.

Our leadproduct candidate,palazestrant, isa novel, orallyavailablecomplete estrogen receptor antagonist (CERAN)and selective estrogen receptor degrader (SERD)currently intwopivotalPhase 3clinicaltrials.We expect top-line data from OPERA-01,ourongoingPhase 3 trial ofpalazestrantas a monotherapy in patients withsecond- or third-lineER+/HER2-metastatic breast cancer (MBC), in the fallwhich, if successful, could lead to our first potentialapproval andcommercial launchin 2027. OPERA-02,ourPhase 3 trial ofpalazestrantin combination withribociblibin patients with frontlineER+/HER2- MBC, isenrolling patients.Togetherwith itsmechanism of action, pharmacokinetic properties,andthe potential todemonstrateactivity in bothESR1wild-type and mutant tumors,palazestranthas the potential totransform the metastatic breast cancer treatment paradigm andaccessa$15 billionglobal market opportunity.

Our follow-on product candidate, OP-3136, is a potent KAT6 inhibitor withthepotential to generate further value and meaningfullyimpactthemetastatic breastcancertreatment landscape – particularly in combination withpalazestrant.We recently reportedencouragingPhase 1monotherapydata from this programacross multiple solid tumor types andareadvancingpatientenrollment in theongoingcombinationarmsin MBC.

Aspiring to transform the metastatic treatment paradigmis an ambitious endeavor that requires aresolute approach todeveloping better therapies and apassionateteamdedicated tohelping the patients we serve feelbetter,longer.Wepossessadeepcommitment toour shared purpose,thesustained pursuit of excellence, cultivatingthecouragerequiredto advance our programs, drive to succeed, and a collective capacity for adaptability through learning, growth, and evolution. Team Olema is made up of nimble self-starters who bring consistency in their quest for the extraordinary every single day.

Ifyou’rereadyto bepartof atenacious,courageous,agile, andgrowingteam,join us in makinga 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 inaccomplishingour 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

#LI-MK1

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 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.