Job details Salary TBA. Estimated range: 200-235K base LocationSan Carlos, California Employment type Permanent Discipline Life Sciences Job description Director, Regulatory Affairs Location: San Mateo, CA Position Overview: The Director of Regulatory Affairs will lead global regulatory activities with a focus on clinical filings. This role involves guiding regulatory strategy, managing submissions, supporting clinical trial applications, and ensuring compliance with regulatory requirements. Key Responsibilities: Lead global regulatory strategy and planning, focusing on clinical regulatory filings. Oversee IND submissions, ensuring compliance with regulatory standards. Manage the preparation, review, and tracking of regulatory documents. Provide guidance on regulatory requirements to project teams and governance bodies. Coordinate with vendors to ensure timely communication and deliverables. Manage interactions with regulatory agencies and respond to inquiries. Ensure proper review, finalization, and archiving of regulatory submissions. Required Qualifications: BA/BS degree in biological or physical sciences preferred. At least 6 years of regulatory science experience, including experience with US eCTD IND submissions and ex-US CTAs. Proficiency in written, oral, and interpersonal communication. Strong attention to detail, organizational skills, and ability to prioritize tasks. Experience with MS Office and electronic document management systems. Ability to collaborate effectively with colleagues across departments. Ability to thrive in a fast-paced, entrepreneurial environment. Preferred Experience: Experience interacting with CROs for US eCTD IND submissions and ex-US CTAs. Disclaimer: This job description outlines the general nature and level of work expected for this role. It is not an exhaustive list of all responsibilities, duties, and skills required.