Vice President, Global Regulatory Affairs at Mozart Therapeutics, Inc. – Seattle, Washington

Mozart Therapeutics is an early clinical phase biopharmaceutical company located in Seattle, focused on developing novel immune engagers that specifically target a subset of T lymphocytes to delay the onset and ameliorate pathology of autoimmune diseases. We are developing first-in-class immune modulators that specifically target a novel regulatory T cell network. The company is seeking a highly motivated and experienced individual to join our team. The ideal candidate will work in a dynamic start-up environment to perform biorepository management of our clinical samples, collaborating with teams across the company, clinical trial sites, and laboratories. They will join a team focused on the discovery, generation, and development of therapeutic candidates in inflammatory and autoimmune disease.

The VP, Global Regulatory Affairs will define and drive the global regulatory strategy for all Mozart programs. In this leadership role, you will design innovative, phase-appropriate regulatory pathways; lead major global submissions; and serve as the company’s primary interface with regulatory authorities and partner organizations worldwide. Success looks like efficient development, strong compliance, and clear alignment with corporate objectives.

You will collaborate closely with Program Management, Clinical Development, Operations, Translational Medicine, Clinical Pharmacology, Nonclinical Toxicology, CMC, and Biostatistics to ensure scientific rigor, operational excellence, and regulatory success.

KEY RESPONSIBILITIES:

Set the Strategy: Develop and execute integrated global regulatory strategies across all programs, optimizing for speed, risk mitigation, and approval readiness.

Own Submissions: Oversee the authorship, review, and delivery of core regulatory documents, including pre-IND and IND packages, Investigator’s Brochures, clinical protocols and amendments, DSURs/PSURs, Clinical Study Reports, pediatric plans (as applicable), and global marketing applications.

Leadership: Lead interactions with FDA, EMA, PMDA, HREC and other global authorities; plan and conduct scientific advice/protocol assistance, and pre-submission meetings; ensure robust briefing packages and clear meeting outcomes.

Writing: Drive and participate in writing clinical trial documents, such as Investigator Brochures, Clinical Protocols and amendments, regular update reports (DSURs), Clinical study reports in collaboration with partners, CROs and internal project team.

Innovate Thoughtfully: Provide and execute innovative approaches to resolve complex regulatory issues and to increase speed to clinical trials for the good of patients.

Cross-Functional Partner: Partners with Clinical Pharmacology, CMC, Clinical Operations and Clinical Development to define and achieve product development objectives.

Quality & Compliance: Partner with Quality Assurance to maintain robust, compliant quality systems and ensure regulatory strategies, submissions, and product development activities meet global quality and compliance standards.

Governance & Communication: Present strategy, risk assessments, and decision points to executive leadership and governance committees; drive alignment and timely decisions.

KNOWLEDGE, SKILLS, AND ABILITIES:

• Successful track record in the development of biologics for the treatment of inflammatory and autoimmune disease highly preferred. Experience with type-1-diabetes and/or inflammatory bowel disease strongly preferred.
• Successful track record of leading IND/CTA, NDA, and/or BLA submissions and engaging in the approval process.
• Extensive knowledge of clinical development, regulations of FDA, EMA, PMDA, HREC and international global clinical trial regulations
• Extensive experience in interactions with FDA, EMA, PMDA, CFDA.
• Working familiarity with innovative and adaptive clinical trial designs
• Knowledge of GxP regulations and ICH and FDA guidelines
• Experience in global submissions and approvals in Europe and Asia-Pacific
• Ability to blend analytical and critical thinking skills to enable data-driven, strategically oriented review of regulatory documents.
• Demonstrated leadership communication, analytic, problem-solving, organizational, and negotiation/decision-making skills.
• Nimble, creative, entrepreneurial with the ability to independently execute.
• Track record to collaborate with and mentor talents.
• Demonstrated ability to work in an innovative and fast-paced environment.
• A highly collaborative team player who fosters open communication and facilitates mutual understanding and cooperation between all stakeholders.

EDUCATION AND EXPERIENCE:

• Ph.D., Pharm.D. or equivalent training in pharmaceutical sciences or a related field
• 15 years' biopharmaceutical experience, including at least 10 years of direct experience in Regulatory Affairs and 5 years in a leadership role.

COMPENSATION & BENEFITS:

The salary range is $288,000 min to $352,000 max. Fully qualified candidates will be paid in proximity to the salary mid-point. The wage range shown is based on the job posting’s primary location. Actual compensation packages are based on a wide array of factors, including but not limited to skill set, experience, certifications, and location, in addition to internal equity and alignment with market data.

We offer our employees competitive compensation including annual performance bonuses and stock option grants. Benefits include paid vacation, sick leave, and holidays, medical, dental and vision insurance, life and long-term disability insurance, 401(k) with company matching. All benefits are non-contractual and may be amended, terminated, or enhanced as Mozart Therapeutics deems necessary.

Mozart is an equal opportunity employer. We encourage candidates from all backgrounds to apply and join us in our mission.