Job reference #: CSBAY202102 Company Description: CS-Bay Therapeutics Inc. is a well-funded private biopharmaceutical company located in Newark, California that is dedicated to meet unmet medical needs with innovative therapeutics. Our projects are designed to harness multiple components of the immune system to combat a wide range of cancers. CS-Bay has a robust portfolio of fully-owned, novel drug candidates at various stages of discovery and development. Job Description: We are looking for qualified candidates for Associate Director/Director, Regulatory Affairs position to join our dynamic and highly collaborative team focused on the development of innovative next-generation cancer therapeutics. The Director, Regulatory Affairs will be responsible for providing regulatory leadership and support for CS-Bay Therapeutics’ development programs and preparing and submitting FDA and NMPA submissions for approval. Positions will be filled based on candidate’s level of experience. Responsibilities: 1. Provide strategic regulatory input for development projects to ensure programs advance efficiently. 2. Collaborate and coordinate with team members across disciplines to generate regulatory documents that are required for world submissions and coordination of such activities within the company. 3. Identify potential program level regulatory risks and development of mitigation strategies. 4. Interpret existing or new regulatory requirements as they relate to company products, clinical studies, testing, or records keeping. 5. Review, analyze and approve technical data generated by Research and Development, Manufacturing, Marketing, Clinical Research, Quality Assurance or other related departments for filing purposes. 6. Manage global strategic regulatory interactions, including development of relevant supporting documentation. 7. Oversee study related regulatory interactions, including CTA submissions and responses to questions from regulatory agencies. 8. Coordinate meetings with regulatory agencies. 9. Oversee external regulatory service providers and consultants. Qualifications: 1. BS/MS Degree with 8+ year of relevant progressive regulatory affairs management experience in the drug development. 2. Demonstrated experience in the biotech/pharmaceutical industry including an ability to manage in a matrixed project team environment including coordination of all cross-functional aspects of drug development (e.g., preclinical, CMC, regulatory, clinical, quality, etc.) to achieve regulatory filing goals. 3. Must have a solid knowledge of US and China regulatory processes. 4. Experience in both small and large molecule drug development is highly desirable. 5. Experience in oligonucleotides and/or PEGylation product is highly desirable. 6. Experience leading meetings and teleconferences with regulatory agencies. 7. Demonstrated record of accomplishment; proven track record of coordinating and authoring regulatory documents. 8. Strong leadership, excellent oral and written communication skills, and enthusiasm for contributing in a fast-paced and innovative environment. 9. Fluency in Mandarin is desirable, but not required. What We Offer: CS-Bay Therapeutics Inc. offers a competitive salary and benefits package. Where to Submit Your Application: Please send your resume and cover letter to hr.csbay@csbaytherapeutics.com, and include “CSBAY202102” in the subject line. CS-Bay Therapeutics Inc. is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, protected veteran status, or disability status, or any other characteristic protected by law.