Senior Director/ Executive Director, Regulatory Affairs

Dren Bio, Inc.; San Carlos (CA); On-site; USD 230,000 - 280,000; Full time

Benefits offered by this job

Equity incentive awards

Employer sponsored benefits

Job summary

Dren Bio, Inc. is seeking a Senior Director/Executive Director of Regulatory Affairs to lead global regulatory strategy from clinical development through marketing approval.

You will partner with cross-functional teams and manage interactions with the FDA and other health authorities to drive expedited pathways and successful BLA submissions. Ideal candidates bring 12+ years in regulatory affairs for biologics, with strong leadership, strategic thinking, and hands-on regulatory execution.

Qualifications

• Bachelor's degree in a scientific, life sciences, pharmacy, or related discipline.
• Minimum of 12+ years of progressive regulatory affairs experience in biotechnology or pharmaceutical industry.
• Experience leading regulatory strategy for biologics with direct FDA interaction.
• Experience leading or playing a major regulatory leadership role in BLA planning and submissions; PRIME/RTOR experience is a plus.

Responsibilities

• Lead global regulatory strategy for designated development programs, integrating clinical/nonclinical/CMC/safety into dated regulatory plans.
• Provide proactive regulatory guidance to optimize drug development and marketing authorization strategies across regions.
• Lead FDA interactions, including meeting strategy, briefing materials, and follow-up commitments.
• Lead regulatory strategy and execution for BLA submissions end to end, including content strategy and cross-functional coordination.
• Develop and execute expedited-pathway strategies (Fast Track/Breakthrough/Orphan/PRIME) and manage EMA interactions.
• Coordinate regulatory planning for rolling submissions and Real-Time Oncology Review (RTOR) where applicable.

Skills

Regulatory strategy

FDA interactions

BLA submissions

Lead cross-functional teams

Regulatory writing

Education

Bachelor's degree in a scientific field

MS/PharmD/PhD preferred

Job description

Senior Director/ Executive Director, Regulatory Affairs

About the Company:

Dren Bio is a privately held, clinical-stage biopharmaceutical company pioneering thediscovery and development of first-in-class antibody therapeutics for the treatment ofcancer, autoimmune disorders, and other serious diseases. Leveraging our wholly ownedtechnologies, we have built a robust R&D pipeline, including two clinical-stage candidatescurrently being evaluated across multiple ongoing clinical studies. Our lead clinicalcandidate, dibotatug, is designed to induce antibody-mediated killing of a specific celltype implicated in a range of oncology and autoimmune indications. In addition, we havelaunched multiple programs from our proprietary Targeted Myeloid Engager and PhagocytosisPlatform, a multispecific antibody-based technology engineered to selectively engage a novelphagocytic receptor expressed on myeloid cells (antigen presenting cells) for the targeteddepletion of pathologic cells and other disease-causing agents. Data generated using theplatform support its broad therapeutic potential, including initial programs focused ononcology, immunology, and neurology. Importantly, multispecific antibodies generated fromthe platform are specially designed to activate phagocytic mechanisms only in the presenceof disease targets, potentially offering a superior safety profile compared to otherimmunomodulatory therapies. For more information, please visit our website atwww.drenbio.com.

Function:

Regulatory Affairs

Level:

Senior Director / Executive Director

Reporting Manager:

SVP, Regulatory Affairs

About the Opportunity:

Dren Bio is seeking an experienced regulatory leader to provide strategic leadership fordevelopment programs and guide global regulatory strategy from clinical development throughmarketing application and approval. This role will serve as a senior regulatory partner tocross-functional teams, with particular responsibility for interactions with the U.S. Foodand Drug Administration (FDA) and other global health authorities, for expedited-pathwaystrategy (including PRIME and Real-Time Oncology Review), and for the strategy, planning,preparation, and submission of Biologics License Applications (BLAs). The successfulcandidate will combine strategic judgment with a hands‑on approach to regulatory executionand will work closely with Clinical Development, Clinical Operations, CMC, Quality, Safety,Biostatistics, Medical Writing, and other internal and external partners to advancedevelopment and registration objectives.

Role and Responsibilities:

Lead and deliver global regulatory strategy for designated development programs,integrating clinical, nonclinical, CMC, safety, and other functional considerationsinto clear, dated regulatory plans and filing sequences.

Provide proactive regulatory guidance to optimize drug development and marketingauthorization strategies in the United States, Europe, and other identified regions.

Lead FDA interactions, including development of meeting strategy, briefing materials,key messages, team preparation, meeting participation, and follow-up on agencyfeedback and commitments.

Lead regulatory strategy, planning, and execution for BLA submissions end to end,including submission readiness, integrated cross-functional planning, contentstrategy, review, and responses to health authority questions through review andpotential approval.

Develop and execute expedited-pathway strategy, including requests for Fast Track,Breakthrough Therapy, orphan drug, and EMA PRIME designation; lead the preparationand submission of PRIME eligibility requests and manage the resulting enhanced EMAinteractions.

Evaluate and, where appropriate, lead strategy and planning for FDA Real-TimeOncology Review (RTOR) and related Oncology Center of Excellence programs (such asProject Orbis and Assessment Aid), including submission readiness for rolling, earlydata sharing with the agency.

Lead interactions with global health authorities, including the EMA, MHRA, PMDA,Health Canada, and other regional regulators; guide scientific advice, PediatricInvestigation Plan/Pediatric Study Plan alignment, and regional filing strategy, andcoordinate concurrent or staggered submissions across regions.

Provide strategic oversight for regulatory submissions and communications, includingINDs/CTAs and amendments, meeting requests and briefing packages, expedited programand designation requests, annual reports, and marketing applications (BLA, MAA, andothers), as applicable.

Anticipate regulatory risks, identify options and mitigation strategies, andcommunicate recommendations and implications to program teams and senior leadership.

Interpret FDA and other health authority regulations, guidance, precedent, andevolving regulatory expectations and translate them into practical development andsubmission strategies.

Partner closely with Clinical Development, Clinical Operations, CMC, Quality, Safety,Biostatistics, Medical Writing, and other functions to ensure regulatoryrequirements and agency feedback are incorporated into development plans anddeliverables.

Oversee the timely preparation and finalization of high-quality, scientificallyaccurate regulatory documents and submissions; contribute directly to strategicdocuments and critical submission content as needed.

Build and maintain effective working relationships with the FDA and other relevanthealth authorities and represent Dren Bio in regulatory interactions in a clear,credible, and collaborative manner.

Contribute to regulatory processes, standards, and ways of working that supportsubmission quality, inspection readiness, and efficient execution as programsadvance.

Provide regulatory leadership, coaching, and mentorship to colleagues and projectteams; management responsibilities may be included based on organizational needs andcandidate experience.

Education, Experience and QualificationRequirements:

Bachelor's degree in a scientific, life sciences, pharmacy, or related discipline isrequired; an advanced degree (MS, PharmD, PhD, or equivalent) is preferred.

Minimum of 12+ years of progressive regulatory affairs experience in thebiotechnology or pharmaceutical industry, with level and scope commensurate withSenior Director or Executive Director responsibilities.

Demonstrated experience leading regulatory strategy for biologic products acrossclinical development, with significant direct experience interacting with the FDAand exposure to other global health authorities (e.g., EMA, MHRA, PMDA, HealthCanada).

Hands-on experience leading or playing a major regulatory leadership role in at leastone BLA planning and submission process is required; experience carrying a BLAthrough health authority review to approval is strongly preferred.

Direct experience developing and executing expedited-pathway strategy (Fast Track,Breakthrough Therapy, orphan drug, accelerated approval, and/or PRIME) is required;experience obtaining PRIME eligibility is strongly preferred.

Experience with FDA Real-Time Oncology Review (RTOR) or other rolling andearly-submission review programs is highly desirable, as is oncology developmentexperience.

Core Competencies, Knowledge and SkillRequirements:

Deep knowledge of FDA regulations, guidance, and regulatory expectations fordevelopment and registration of biologic products, including expedited programs;working knowledge of ICH, EU (EMA/PRIME), and other relevant global regulatoryframeworks.

Proven ability to develop and communicate integrated regulatory strategies, evaluateregulatory precedent, and translate agency feedback into actionable developmentplans, including where precedent is limited or evolving.

Strong BLA expertise, including regulatory strategy, submission planning, content andreadiness oversight, cross-functional coordination, and management of healthauthority questions during review.

Working knowledge of expedited and real-time review mechanisms, including PRIME,Breakthrough Therapy, RTOR, and Project Orbis, and the ability to determine when andhow to pursue them.

Demonstrated success leading FDA and other global health authority meetings andpreparing cross-functional teams for high-impact health authority interactions.

Ability to critically review complex clinical, nonclinical, CMC, safety, andstatistical information and identify regulatory implications, risks, andopportunities.

Excellent regulatory writing, communication, negotiation, and presentation skills,with the ability to communicate complex issues clearly to technical teams and seniorleaders.

Strong cross-functional leadership and influencing skills, including the ability tobuild alignment and drive decisions without relying on formal authority.

Strategic and pragmatic problem-solving skills with sound judgment in ambiguous orevolving situations.

Ability to manage multiple priorities and high-impact deliverables in a fast-pacedbiotechnology environment while maintaining quality and attention to detail.

Salaries, Benefits and Other Employee Perks:

Dren Bio strongly believes in investing in, and rewarding, its employees. This philosophy isembodied in the Company’s total rewards program, which includes competitive cashcompensation, equity incentive awards, and employer sponsored benefit offerings. The basepay range for this position at commencement of employment is expected to be between $230,000and $280,000 per year. At Dren Bio, pay ranges are determined by role, level(s), andlocation. The range displayed in this job posting reflects the minimum and maximum new hirepay for candidates located across all United States job markets. Within the range,individual pay will be determined by work location and additional factors, includingjob-related skills, experience, and relevant education or training. During the hiringprocess, Dren Bio’s Human Resources department can share more about the specific pay rangebased on the market location of the candidate.

Employment Practices:

Dren Bio is an equal opportunity employer. Employment decisions are based on merit andbusiness needs. Dren Bio will not discriminate against any job applicant because of race,color, national origin, ancestry, gender, sexual orientation, age, religion, creed, physicalor mental disability, gender identity, medical condition, pregnancy, marital status, veteranstatus, or any other characteristic protected by federal, state or local law.