Senior Manager, Global Regulatory Affairs Strategy at Olema Oncology

San Francisco, California, United States -

Full Time

Start Date

Immediate

Expiry Date

29 Jun, 26

Salary

188000.0

Posted On

31 Mar, 26

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Regulatory Strategy, Cross Functional Teamwork, Clinical Trial Submissions, INDs, CTAs, Amendments, Briefing Documents, Investigator Brochures, Health Authority Interactions, Project Management, Risk Assessment, Mitigation Planning, SOP Development, Vendor Management, Regulatory Landscape Monitoring, Problem-Solving

Industry

Biotechnology Research

Description

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, Global Regulatory Affairs Strategy As the Senior Manager, Global Regulatory Affairs Strategy, reporting to the Senior Director, Global Regulatory Affairs Strategy, 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. You will represent Regulatory Affairs on cross-functional teams, lead the planning and preparation of clinical trial submissions (INDs, CTAs, amendments, briefing documents, Investigator Brochures) and support global health authority interactions. This role can be based out of our Boston, MA or San Francisco, CA office and will require domestic and international travel, approximately 10–15% Your Work Will Primarily Encompass: With limited supervision, support the development and execution of global regulatory strategies for products in Olema’s pipeline, with a focus on early development and clinical trial applications Serve as the Regulatory Affairs representative on global project teams and Study Execution Teams, providing regulatory input and ensuring alignment with program objectives and timelines Prepare and coordinate high-quality regulatory global submissions, including INDs, CTAs, amendments, annual reports, DSURs, Investigator Brochures, and briefing documents Under the supervision of the Senior Director, Regulatory Affairs, contribute to planning and execution of regulatory interactions with health authorities (e.g., FDA, EMA, Health Canada, MHRA), including meeting requests, briefing packages, and follow-up correspondence Monitor the global regulatory landscape to identify requirements, trends, and potential impact on Olema’s development programs Coordinate and maintain health authority reporting schedules in collaboration with cross-functional teams Partner with external vendors (e.g., CROs, regulatory consultants) to ensure high-quality and timely submissions Support development of Regulatory Affairs departmental policies, SOPs, and systems (e.g., Veeva) to enhance submission quality and efficiency Assist in risk assessment and mitigation planning for regulatory deliverables Ideal Candidate Profile We are looking for a collaborative and driven Regulatory Affairs professional who thrives in a fast-paced environment and brings expertise in regulatory strategy Knowledge: Bachelor’s degree in a scientific discipline required; advanced degree (MS, PharmD, PhD) preferred Experience: Minimum 7 years of related experience with a Bachelor’s degree; or 5 years and a Master’s degree; or a PhD with 3 years experience; regulatory affairs experience in the pharmaceutical or biotechnology industry Direct experience preparing and submitting clinical trial applications (INDs, CTAs) and managing regulatory authority correspondence Knowledge of global regulatory requirements for clinical development (FDA, EMA, ICH guidelines) Oncology therapeutic area experience preferred Experience collaborating in cross-functional, matrixed teams Experience working with CROs and other partners Attributes: Strong organizational, project management, and problem-solving skills Excellent oral, written, and presentation skills Flexible and proactive, with the ability to manage multiple projects and adapt to changing priorities Self-starter with the ability to work both independently and within teams The base pay range for this position is expected to be $176,000 - $188,000 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. #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 @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.

Responsibilities

The Senior Manager will provide regulatory strategy support, partnering with cross-functional teams to manage regulatory aspects throughout all development phases, including representing Regulatory Affairs on project teams. This role involves leading the planning and preparation of clinical trial submissions such as INDs and CTAs, and supporting interactions with global health authorities.