Director, Global Regulatory Affairs

Angitia Biopharmaceuticals

. Lead the development and execution of global regulatory strategies for assigned development programs .

Posted 10/5/2026full-timeRemote • California • United StatesLead💰 $180,000 - $230,000 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in leading global regulatory strategies and submissions, with a strong focus on compliance and quality across nonclinical, clinical, and CMC activities. Proven ability to influence cross-functional teams and mentor junior professionals while navigating complex regulatory environments.

Highest-signal resume keywords

Regulatory Affairs StrategyGlobal Regulatory SubmissionsHealth Authority InteractionsRegulatory Requirements KnowledgeCross-Functional Team Leadership

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Regulatory Strategy DevelopmentRegulatory Submissions (INDs, CTAs)Lifecycle ManagementRisk Assessment and MitigationStudy Design and Endpoint DevelopmentRegulatory Frameworks (US, EU, Japan)Orphan Drug DevelopmentRegulatory ComplianceScientific WritingProject Management

Soft Skills

Strategic ThinkingProblem-SolvingDecision-MakingExcellent CommunicationInterpersonal Skills

Certifications & Qualifications

Bachelor's Degree in Life SciencesAdvanced Degree (PharmD, MS, PhD, MBA)

Industry Keywords

PharmaceuticalBiotechnologyRegulatory AffairsGlobal Development ProgramsMultinational EnvironmentsCross-Functional CollaborationRegulatory Authorities (FDA, EMA, PMDA)Rare DiseaseConsultantsContractors

About the role

Key responsibilities & impact

Lead the development and execution of global regulatory strategies for assigned development programs
Lead the product's Global Regulatory Team and represent Regulatory Affairs on governance and cross-functional development teams
Provide regulatory leadership across nonclinical, clinical, CMC, registration, and lifecycle management activities
Partner with cross-functional teams to shape development plans, study designs, endpoints, and regulatory pathways
Identify regulatory risks and opportunities and develop mitigation and management recommendations
Lead regulatory strategy and execution for health authority interactions, including meeting preparation, briefing materials, and responses
Provide strategic oversight and direction of major regulatory submissions, including INDs, CTAs, amendments, and marketing applications
Direct global and regional submission strategies with regional regulatory stakeholders
Ensure regulatory submissions are scientifically sound, strategically aligned, and high quality
Monitor evolving regulatory requirements and assess their impact on development programs
Build and maintain relationships with regulatory authorities, consultants, contractors, and partners
Influence cross-functional teams to achieve program objectives while balancing regulatory and business considerations
Mentor junior regulatory professionals and contribute to departmental initiatives, process improvements, and capability development
Provide regulatory recommendations and strategic input to senior management and governance committees
Maintain a global perspective and promote alignment across programs, regions, and functional areas

Requirements

What you’ll need

Bachelor's degree in Life Sciences or related discipline; advanced degree preferred (PharmD, MS, PhD, MBA, or equivalent)
10+ years of pharmaceutical or biotechnology experience, including at least 8 years in Regulatory Affairs strategy
Significant experience supporting global development programs through registration and lifecycle management
Strong knowledge of regulatory requirements and frameworks in the US, EU, and Japan
Experience leading interactions with health authorities, including FDA, EMA, and PMDA
Experience developing major regulatory submissions and regulatory strategies
Experience in rare disease, orphan drug development, or other specialized development pathways is preferred but not required
Demonstrated ability to lead and influence cross-functional matrix teams
Strong strategic thinking, problem-solving, and decision-making skills
Excellent communication, presentation, and interpersonal skills
Strong organizational skills and ability to manage multiple priorities
Experience working in multinational and multicultural environments

Benefits

Comp & perks

Medical, dental, and vision coverage for employees and their eligible dependents
401(K) Retirement Plan with Company match
Company paid Long Term Disability Coverage
Company-paid life Insurance & AD&D Coverage
Voluntary Life Insurance & AD&D Coverage
Employee Assistance Program (EAP)
Company-paid Holidays
Vacation
Paid Sick Leave
Telecommunication Monthly Stipend
Work-From-Home Equipment Reimbursement