Vice President, Global Regulatory Affairs

Mozart Therapeutics, Inc. • Seattle, WA

56d • Onsite

About The Position

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.

Requirements

• 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.
• 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.

Nice To Haves

• Successful track record in the development of biologics for the treatment of inflammatory and autoimmune disease
• Experience with type-1-diabetes and/or inflammatory bowel disease

Responsibilities

• Develop and execute integrated global regulatory strategies across all programs, optimizing for speed, risk mitigation, and approval readiness.
• 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.
• 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.
• 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.
• Provide and execute innovative approaches to resolve complex regulatory issues and to increase speed to clinical trials for the good of patients.
• Partners with Clinical Pharmacology, CMC, Clinical Operations and Clinical Development to define and achieve product development objectives.
• 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.
• Present strategy, risk assessments, and decision points to executive leadership and governance committees; drive alignment and timely decisions.

Benefits

• competitive compensation including annual performance bonuses and stock option grants
• paid vacation
• sick leave
• holidays
• medical, dental and vision insurance
• life and long-term disability insurance
• 401(k) with company matching

What This Job Offers

• Job Type: Full-time
• Career Level: Executive
• Education Level: Ph.D. or professional degree
• Number of Employees: 1-10 employees