CAssociate Director/ Director, Regulatory Affairs

CAssociate Director/ Director, Regulatory Affairs Employer Dren Bio Location San Carlos, CA Start date Jun 13, 2026 View more categories View less categories Discipline Regulatory , Regulatory Affairs Required Education Bachelors Degree Position Type Full time Hotbed Biotech Bay Apply now Save job Click to add the job to your shortlist You need to sign in or create an account to save a job. Send job Job Details Company Job Details CAssociate Director/ Director, Regulatory Affairs About the

Company:

Dren Bio is a privately held, clinical-stage biopharmaceutical company pioneering the discovery and development of first-in-class antibody therapeutics for the treatment of cancer, autoimmune disorders, and other serious diseases. Leveraging our wholly owned technologies, we have built a robust R D pipeline, including two clinical-stage candidates currently being evaluated across multiple ongoing clinical studies. Our lead clinical candidate, dibotatug, is designed to induce antibody-mediated killing of a specific cell type implicated in a range of oncology and autoimmune indications. In addition, we have launched multiple programs from our proprietary Targeted Myeloid Engager and Phagocytosis Platform, a multispecific antibody-based technology engineered to selectively engage a novel phagocytic receptor expressed on myeloid cells (antigen presenting cells) for the targeted depletion of pathologic cells and other disease-causing agents. Data generated using the platform support its broad therapeutic potential, including initial programs focused on oncology, immunology, and neurology. Importantly, multispecific antibodies generated from the platform are specially designed to activate phagocytic mechanisms only in the presence of disease targets, potentially offering a superior safety profile compared to other immunomodulatory therapies. For more information, please visit our website at www.drenbio.com.

Function:

Regulatory Affairs Level:

Associate Director/ Director Location:

San Carlos, CA Reporting Manager:

SVP, Regulatory Affairs About the

Opportunity:

Dren Bio is seeking an experienced and talented individual who will provide regulatory strategic guidance on development programs, as well as oversee the writing, preparation and finalization of regulatory submissions and communications with various world-wide health authorities. The position requires a hands-on, self-starter who works well in partnership with internal colleagues and external partners. This person will also be responsible for advising on regulatory compliance matters. Title, compensation and scope of duties will be tailored to the successful candidate's experience.

Role and Responsibilities:

The Associate Director/Director of Regulatory Affairs is accountable for the deliveryof regulatory strategy for designated programs at DrenBio. Proactively develop and provide regulatory guidance on strategies for optimal drugdevelopment and marketing authorization in the United States and other identifiedregions. Contribute to team and corporate product development decisions in the context ofapplicable laws, regulations, and guidance from health authorities. Lead all regulatory communications with and submissions to the US-FDA and otheridentified health authorities (eg, INDs/CTAs, expedited designations [eg,fast-track, breakthrough, prime], orphan drug applications, pediatric investigationplans, development/scientific advice, marketing applications). Oversee timely writing, preparation, and finalization (including actively writingregulatory documentation) of scientifically valid/accurate submissions that arecompliant to the applicable health authority requirement. Develop and maintain strong relationships with the FDA and other identified healthauthorities to foster close partnerships geared towards optimizing productdevelopment and registration. Contribute to establishing and administering internal regulatory policies andprocedures to achieve best practices work processes. Stay abreast of newly issued regulatory laws and guidance as well as technicalpublications, articles, and abstracts to promptly identify possible impact orimprovements to product programs. Participate in professional and industry organizations to follow regulatory trends,influence development of regulations and guidance, and develop relationships torepresent the interests of the company. Work with Quality and other departments to ensure data accuracy and integrityrelating to health authority submissions and reporting requirements. Participate in corporate partnership efforts.

Education, Experience and Qualification Requirements:

Bachelor's degree in a scientific field (eg, Clinical, Biological, Mathematical) isrequired; an advanced degree is a plus. Minimum of 10 years for Associate Director or 12+ years for Director in regulatoryaffairs in Biotechnology or comparable experience.

Core Competencies, Knowledge and Skill Requirements:

Good background in biological/physical science and the ability to apply thatknowledge to regulatory issues. Prior regulatory submissions experience in biotechnology product development,particularly with investigational new drug applications in the US, Europe, andAustralia. Experienced with regulatory agency interactions and in preparing teams for meetingswith health authorities. Good writing skills and able to effectively describe complex situations in regulatorydocuments. The ability to be a productive team member, capable of making effective,knowledgeable contributions. Must be well-organized and capable of handling multiple priorities. Proven ability in creative problem solving and the ability to eliminate roadblocks todevelopment. Possess a strong interpersonal skill that fosters a proactive approach to workingcross-functionally on development teams.

Salaries, Benefits and Other Employee Perks:

Dren Bio strongly believes in investing in, and rewarding, its employees. This philosophy is embodied in the Company's total rewards program, which includes competitive cash compensation, equity incentive awards, and employer sponsored benefit offerings. The base pay range for this position at commencement of employment is expected to be between $170,000 and $220,000 per year. At Dren Bio, pay ranges are determined by role, level(s), and location. The range displayed in this job posting reflects the minimum and maximum new hire pay for candidates located across all United States job markets. Within the range, individual pay will be determined by work location and additional factors, including job-related skills, experience, and relevant education or training. During the hiring process, Dren Bio's Human Resources department can share more about the specific pay range based on the market location of the candidate.

Employment Practices:

Dren Bio is an equal opportunity employer. Employment decisions are based on merit and business needs. Dren Bio will not discriminate against any job applicant because of race, color, national origin, ancestry, gender, sexual orientation, age, religion, creed, physical or mental disability, gender identity, medical condition, pregnancy, marital status, veteran status, or any other characteristic protected by federal, state or local law. Company Dren Bio is a privately held, clinical-stage biopharmaceutical company pioneering the discovery and development of novel antibody therapeutics that selectively deplete pathogenic cells and other disease-causing agents. Dren's pipeline comprises two first-in-class clinical stage programs being evaluated in various oncology and autoimmune diseases, as well as multiple preclinical and discovery stage programs focused on oncology, immunology, and neurology derived from its proprietary Targeted Myeloid Engager and Phagocytosis Platform.

Company info Website https:

//www.drenbio.com/ Location 835 Industrial Rd, Suite 400 San Carlos

CA 94070

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