Senior Manager, Regulatory Affairs Operations

Senior Manager, Regulatory Affairs Operations Base pay range: $175,000 - $190,000 per year. Based in either San Francisco or Cambridge, CA. Requires approximately 10‑15% travel. As the Senior Manager of Regulatory Affairs Operations, reporting to the Director of Regulatory Affairs Operations, you will provide global regulatory operations support for the advancement of multiple clinical trials. This role provides leadership in the operational guidance and execution of regulatory concepts within cross‑functional project teams and supports interactions with global health authorities and corporate partners with regulatory deliverables. Responsibility Serve as a Regulatory Operations Lead on project submission planning and submission processes, while proactively managing critical operational issues to ensure timely submission. Provide regulatory operations expertise and leadership to cross‑functional teams supporting Olema’s pipeline (review clinical protocols, informed consent forms, Investigator’s Brochures, CMC, site documentation, etc. for regulatory compliance). Oversee and prepare documentation to support global regulatory filings to ensure accuracy, applicability, consistency, and control of regulatory documents; interact with SMEs for content accuracy. Assist the Global Regulatory Lead in meetings for responses to Health Authority requests, content verification, and follow‑ups with functional leads. Coordinate and prepare responses to Requests for Information from health authorities. Provide regulatory eCTD submission support to INDs, CTAs, IMPDs, NDAs, and other regulatory submissions. Maintain and track all regulatory submissions to Health Authorities and Health Authority correspondences. Provide formatting and QC checks against company style guides and standards to ensure consistency and high quality of finalized submission documents. Provide support and training for Regulatory technologies including Veeva RIM, Veeva Promomats, and StartingPoint templates. Assist with the planning, coordination, and execution of strategic technology initiatives, ensuring deliverables are developed, aligned, and executed effectively across functions. Advise and train on acceptable eCTD and document publishing formats to ensure compliance globally across industry standards. Perform quality assurance of submission documents and published output to ensure compliance with global eCTD requirements. Assist with development and implementation of regulatory processes related to submission standards, working practices, and quality controls. Monitor changes in regulations and keep project teams and management informed of such changes. Maintain expertise with current and future global regulatory submission standards and their implementation within Olema. Build strong partnerships with functions and key stakeholders within Olema, and share knowledge and expertise with teams. Assist in the Director of Regulatory Affairs operations in the management of the departmental budget, contracts, invoices, and PO’s. Ideal Candidate Profile BS or MS in a relevant discipline. Knowledge and experience of eCTD submissions. Knowledge and experience with enterprise document management systems, preferably Veeva RIM. Knowledge and understanding of global industry standards, guidelines, and validation concepts, including eCTD format and registration tracking. Minimum 6+ years pharmaceutical industry experience in Regulatory Affairs. Demonstrated leadership skills while working in a fast‑paced and changing environment. Experience in building and submitting NDA/BLA and life‑cycle management is highly desirable. Displays strong proactive acumen and inclusive engagement to drive decision making, turnaround time improvement, and effective ways of working. Influences the cross‑functional team to adapt fit‑for‑purpose solutions to meet expected timelines. Ability to understand, analyze, and develop recommendations from multiple complex sources such as scientific and operational perspectives. Excellent written and verbal communication skills. Excellent negotiation and organizational skills. Benefits and Compensation The total compensation package includes equity, bonus, and benefits. A summary of benefits is available for all applicants. Equal Opportunity Employer 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. #J-18808-Ljbffr