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Associate Director / Director, Regulatory Affairs

BioSpaceFoster City, CA, United States

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Associate 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, DR-01, is designed to induce antibody‑mediated killing of a specific cell type implicated in a range of oncology and autoimmune indications. We have launched multiple programs from our proprietary Targeted Myeloid Engager and Phagocytosis Platform, a multispecific antibody‑based technology designed to engage phagocytic receptors on myeloid cells for targeted depletion of disease-causing agents. For more information, please visit www.drenbio.com.

Function

Regulatory Affairs

Level

Associate Director / Director

Location

Foster City, CA (moving to San Carlos, CA Sep / Oct 2025)

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.

Role And Responsibilities

Proactively develop and provide regulatory guidance on strategies for optimal drug development and marketing authorization in the United States and other identified regions.
Contribute to team and corporate product development decisions in the context of applicable laws, regulations, and guidance from health authorities.
Lead all regulatory communications with and submissions to the US-FDA and other identified health authorities (eg, INDs / CTAs, expedited designations [eg, fast-track, breakthrough, prime], orphan drug applications, pediatric investigation plans, development / scientific advice, marketing applications).
Oversee timely writing, preparation, and finalization of scientifically valid / accurate submissions that are compliant with applicable health authority requirements.
Develop and maintain strong relationships with the FDA and other identified health authorities to foster close partnerships geared towards optimizing product development and registration.
Contribute to establishing and administering internal regulatory policies and procedures to achieve best practices work processes.
Stay abreast of newly issued regulatory laws and guidance as well as technical publications to promptly identify possible impact or improvements to product programs.
Participate in professional and industry organizations to follow regulatory trends, influence development of regulations and guidance, and develop relationships to represent the interests of the company.
Work with Quality and other departments to ensure data accuracy and integrity relating 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) is required; an advanced degree is a plus.

Minimum of 10 years for Associate Director or 12+ years for Director in regulatory affairs in Biotechnology or comparable experience.

Core Competencies, Knowledge And Skill Requirements

Good background in biological / physical science and the ability to apply that knowledge to regulatory issues.

Prior regulatory submissions experience in biotechnology product development, particularly with investigational new drug applications in the US, Europe, and Australia.

Experienced with regulatory agency interactions and in preparing teams for meetings with health authorities.

Good writing skills and able to effectively describe complex situations in regulatory documents.

Ability to be a productive team member and contribute effectively in cross-functional teams.

Well‑organized with the ability to manage multiple priorities.

Proven ability in creative problem solving and the ability to remove roadblocks to development.

Strong interpersonal skills and proactive cross‑functional collaboration on development teams.

Salaries, Benefits And Other Employee Perks

Dren Bio offers competitive compensation, equity incentive awards, and employer‑sponsored benefits. The base pay range for this position at commencement of employment is expected to be between $170,000 and $220,000 per year. Pay ranges are determined by role, level, and location. Specific pay range details will be shared during the hiring process based on market location and candidate qualifications.

Employment Practices

Dren Bio is an equal opportunity employer. Employment decisions are based on merit and business needs. Dren Bio will not discriminate based on race, color, national origin, ancestry, gender, sexual orientation, age, religion, creed, disability, gender identity, medical condition, pregnancy, marital status, veteran status, or any other characteristic protected by law.

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Director Regulatory • Foster City, CA, United States