Olema Oncology · 21 hours ago
Associate Director, Regulatory Affairs CMC
San Francisco, CA
Full-time
Onsite
Lead/Staff, Director/Executive
$190K/yr - $205K/yr
8+ years expOlema Oncology is dedicated to developing better medicines for breast cancer and beyond. As the Associate Director, Regulatory Affairs CMC, you will be responsible for developing and executing CMC regulatory strategies for Olema product(s) in development and post-approval, ensuring alignment with Health Authority requirements globally.
BiopharmaBiotechnologyHealth CareMedicalOncologyPharmaceutical
Responsibilities
Provide CMC regulatory expertise for global development and registration programs (e.g., INDs, CTAs, BLAs and MAAs)
Support regulatory agency interactions to ensure alignment on CMC strategies for initial INDs/CTAs, marketing registration applications, supplements and variations
Provide CMC support on the global regulatory plan, development plans/clinical study designs and risk assessments
Proactive and effective communication of critical issues and potential mitigations with teams, senior management and key stakeholders in a timely manner
Assess and communicate regulatory requirements to ensure all development activities are in compliance with applicable regulations and guidelines
Manage and ensure compliance with all reporting requirements, including annual and periodic reports
Collaborates well with internal and external teams (CMC, QA, Supply Chain, RA etc)
Assist with the planning, compilation, review, approval and submission of high-quality CMC related sections of regulatory submissions, including responses to questions from various regulatory authorities, working in collaboration with partners in Research, Process Sciences, Manufacturing, QC/QA, Global Supply Chain and other business partners
Provide regulatory support for relevant quality systems such as change control, discrepancy management, and inspection management. Assess proposed manufacturing process changes and provide strategic regulatory guidance to enable global implementation
Support interactions with regulatory agencies during inspections
Maintain up to date knowledge and expertise with FDA/EMA regulations, ICH guidelines and other international regulatory regulations and guidelines, as needed to support global programs
Qualification
Required
Bachelor's degree is required, preferably in a scientific field; advanced degree is a plus
Excellent knowledge of current CMC regulations and regulatory procedures
Excellent working knowledge of international regulatory requirements and environment, including an understanding of GXP
Deep understanding of clinical trial requirements for initial INDs/CTAs for all development phases early to late-stage
Minimum 8 years of experience working in clinical research, biotech, and/or pharmaceutical company, with minimum 6 years of Regulatory Affairs experience within clinical research or pharmaceutical
Experience in small molecule drug development required; experience in the oncology therapeutic area is a plus
Global CMC regulatory experience for clinical trials is required
Post approval (commercial) experience is a plus
Experience with eCTD requirements and electronic submissions
Experience with international regulatory submissions and processes is a strong plus
Strong business acumen and ability to successfully work with international and cross functional partners
Very 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 vision
Proven ability to deliver on goals within a cross-functional team/partnership environment with a high level of professionalism
Excellent verbal, written and presentation skills
Able to analyze, define and effectively convey difficult and complex issues in a way that accurately and persuasively communicates the issues to internal and external stakeholders
Fosters open communication. Listens and facilitates discussion
Maintain learner mindset, with an ability to adapt to an ever-changing environment
Proven ability to prioritize and manage multiple tasks and requests efficiently
Preferred
Experience in the oncology therapeutic area is a plus
Post approval (commercial) experience is a plus
Experience with international regulatory submissions and processes is a strong plus
Benefits
Equity
Bonus
Benefits
Company
Olema Oncology
Olema Oncology is a preclinical biotechnology company that develops new drugs for the treatment and prevention of breast cancer.
51-200 employees
H1B Sponsorship
Olema Oncology has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (4)
2024 (3)
2022 (2)
Funding
Current Stage
Public CompanyTotal Funding
$765.05MKey Investors
Paradigm BioCapital AdvisorsSilicon Valley BankVivo Capital
2025-11-20Post Ipo Equity· $190M
2024-12-02Post Ipo Equity· $250M
2023-09-05Post Ipo Equity· $130M
Leadership Team
Naseem Zojwalla
Chief Medical Officer
Shane Kovacs
Chief Operating and Financial Officer
Recent News
2026-01-13
2025-12-25
Company data provided by crunchbase