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About the Role

Oversee all regulatory activities for the hematology/immunology pipeline, focusing on the Phase 3 clinical trial for VGA039. Develop and implement comprehensive regulatory strategies for timely and successful interactions with global health authorities. Collaborate with cross-functional teams on development strategies and lead global regulatory submissions. Reports to the Chief Development Officer.

Responsibilities

• Lead global regulatory strategy development and execution for all programs.
• Contribute to company culture, strategy, and operations as a Star Management Team member.
• Strategize, lead, write, and supervise development and submission of regulatory documents and plans (e.g., Orphan, Break-Through, Fast-Track, Accelerated-Approval, Diversity, Pediatric Plans).
• Serve as primary contact for global regulatory authorities (FDA, EMA, PMDA), leading all communications and meetings.
• Collaborate with cross-functional teams (Clinical Development, CMC, Quality Assurance) to ensure regulatory compliance and alignment across multiple projects.
• Oversee preparation and submission of global regulatory filings (INDs, CTAs, IBs, DSURs, NDAs).
• Build and maintain relationships with key regulatory community stakeholders.
• Stay current on evolving global regulations and guidance.
• Collaborate with Clinical Development teams to ensure regulatory compliance in clinical trial design, conduct, and reporting.
• Provide regulatory guidance for trials to meet regulatory standards.
• Offer expert guidance and support to internal stakeholders on regulatory matters.
• Develop and manage the Regulatory Affairs department budget.
• Manage contract staff and vendors for regulatory activities.
• Attract, hire, and develop top talent, coaching teams for growth and excellence.
• Provide clarity and strategic direction, empowering teams for smart decision-making and engagement.
• Motivate direct reports through positive feedback and skills development.
• Cultivate a positive, high-performing environment via active engagement and team building.
• Build productive, collaborative relationships across the business, embodying company values.

Requirements

• Advanced Degree (PhD, PharmD, MD) in a scientific discipline (pharmacology or toxicology preferred) or equivalent experience.
• Minimum 15 years of progressive experience in global regulatory affairs within pharmaceutical or biotechnology industry.
• Minimum 5 years experience with rate disease.
• Strong track record of success in late-stage drug development.
• In-depth knowledge of global regulatory requirements, focusing on FDA, EMA, and PMDA.
• Extensive experience preparing and submitting INDs, CTAs, and other regulatory filings (e.g., Orphan, Break-Through, Fast-Track, Accelerated-Approval, Diversity, Pediatric Plans) for global development.
• Previous Phase 3 NDA/global submission experience strongly preferred.
• Experience directly writing submission documents for regulatory filings and clinical trials.

Skills

• Excellent written and oral communication.
• Strong interpersonal skills.
• Leadership skills.
• People-management skills.
• Ability to work as an individual contributor and collaborative team player.
• Flexible and creative thinking.
• Problem-solving skills.
• Excellent organizational skills.
• Attention to detail.
• Excellent time management.
• Proficiency with Microsoft Office Suite or related software.

Location

• South San Francisco, CA

Work Type

• Onsite

Experience Level

• Minimum 15 years of progressive experience in global regulatory affairs.
• Minimum 5 years experience with rate disease.
• Late-stage drug development experience.
• Phase 3 NDA/global submission experience preferred.

Education Level

• Advanced Degree (PhD, PharmD, MD) in a scientific discipline (pharmacology or toxicology preferred)
• Equivalent experience

Salary/Compensations

• $276,000 to $345,000 annually

Benefits

• Competitive benefits package
• Bonus eligibility
• Participation in Company’s equity plan
• Career growth opportunities
• Learning and exploration opportunities
• Opportunities to make connections

About the Company

• Phase 3 clinical stage biotechnology company.
• Aims to discover and develop best-in-class antibody therapies for patients with serious diseases.
• Founded by former True North executives.
• Team with significant scientific, clinical, regulatory, and commercial experience and a demonstrated track record of success.
• Backed by top-tier biotech investors.
• Passionate about bringing innovative therapies to the clinic.
• Committed to patients with limited treatment options.
• Core Value: Patients Are Our Center of Gravity (Partner with patients to address unmet needs).
• Core Value: Propelled by Data, Guided by Intuition, Informed by Expertise (Boldly explore new diseases, novel biology, and smart ways of working with urgency).
• Core Value: Mission Ready Crew (Challenge conventional wisdom and foster an environment of respect and continuous growth).

Equal Opportunity

• Equal opportunity employer, valuing diversity.
• Does not discriminate based on race, religion, color, national origin, gender identity, sexual orientation, age, marital status, veteran status, or disability status.