Senior Manager, Global Regulatory Affairs Strategy

Olema Oncology is dedicated to developing better medicines for breast cancer and beyond. Our lead program, palazestrant (OP-1250), is a complete estrogen receptor antagonist (CERAN) currently in development for metastatic breast cancer with blockbuster potential as a monotherapy and in combination in ER+/HER2- metastatic breast cancer. Our follow-on product candidate, OP-3136, is a potent KAT6 inhibitor with best-in-class potential.  Our scientific breakthroughs are accelerated through the ways in which we fearlessly support, motivate, and challenge one another. At Olema, we know that when we put people first, our work becomes second to none. If you're ready to join us at the edge of something unstoppable, let's make a profound impact together for our patients, for your career, for what's beyond. You can view our latest corporate deck and other presentations here.About the Role >>> Senior Manager, Regulatory Affairs StrategyAs the Senior Manager, Regulatory Affairs Strategy, reporting to the Senior Director, Regulatory Affairs, you will provide regulatory strategy support in partnership with cross functional teams and subject matter experts and manage regulatory aspects through all phases of development. This role is based out of either our San Francisco, CA  or Cambridge, MA office and will require 10% travel. Your work will primarily encompass: Provide regulatory strategy support on regulatory projects Use knowledge of US, EU and ICH regulatory requirements and the ability to apply knowledge both strategically and operationally to development projects and marketed product regulatory issues to support corporate goalsParticipate in the preparation and submission of documentation to support investigational and marketing registration packages throughout the world and ensures timelines are metUnder the guidance of the Global Regulatory Leader, author and/or review sections of IND/CTA, NDA/MAA/NDS, and other global submission documents in support of clinical trials and marketing applications, and their amendments in conformance with local regulatory requirementsUnder the guidance of the Global Regulatory Leader, liaise and negotiate with global regulatory authorities as needed for all aspects pertaining to drug development including resolution of key regulatory issues and to expedite approvals of both product and labeling changesMaintain awareness of the global regulatory environment and assess impact of changes on business and product development programsFacilitate policy and development of standard interpretation of global regulationManage critical issues and leadership for the regulatory contributionIdeal Candidate Profile >>>  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 required; advanced degree preferredThorough understanding of drug development process in the biotechnology or pharmaceutical industry and healthcare environment including regulatory requirements and policy trendsExperience: 8+ years in the biotechnology or pharmaceutical industry and a minimum of 5 years in Regulatory AffairsExperience supporting regulatory submissions for drugs and/or biologics, with oncology experience preferredRegulatory experience with INDs/CTAs, NDAs/BLAs/MAAs, lifecycle management, interactions with Health AuthoritiesInteractions with external business partners and Regulatory AgenciesAttributes: Strong business acumen and ability to successfully work with international and cross functional partnersVery strong strategic skills including creativity and effectiveness in identifying and addressing major strategic challenges (e.g., new competition, shifting market environment) and the ability to balance short-term needs with long-term visionProven ability to deliver on goals within a cross-functional team/partnership environment with a high level of professionalismExcellent verbal and written skills. Fosters open communication. Listens and facilitates discussionAbility to analyze, define and effectively convey difficult and complex issues in a way that accurately and persuasively communicates to internal and external stakeholdersThe base pay range for this position is expected to be $166,000 - $181,000 annually. However the base pay and/or level 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. #LI-MK1 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 Our official corporate website is ; our careers page is ; our LinkedIn page is  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.