Global Regulatory Strategy Director - Remote

Angitia Incorporated Limited; United States; A distancia; USD 180.000 - 230.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Medical benefits

401(K) Retirement Plan

Long Term Disability

Life Insurance & AD&D

Voluntary Life Insurance

Employee Assistance Program

Company holidays

Vacation

Paid Sick Leave

Telecommunication stipend

Work-From-Home equipment reimbursement

Descripción de la vacante

Angitia Biopharmaceuticals seeks a Director, Global Regulatory Affairs to develop and execute global regulatory strategies for development programs. You will serve as the primary regulatory representative on cross-functional teams and provide strategic leadership across all phases of development.

You will partner with Clinical Development, Nonclinical, CMC, Safety, Biostatistics, and Operations to align regulatory strategy with business objectives, representing the company in interactions with

Formación

• 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.
• Experience leading regulatory submissions and interactions with health authorities.

Responsabilidades

• Lead the development and execution of global regulatory strategies for assigned development programs.
• Lead the 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 strategies.
• Lead regulatory strategy and execution for health authority interactions, including meetings and materials.
• Oversee major regulatory submissions (INDs, CTAs, amendments, marketing applications).
• Direct global/submission strategies with regional regulatory stakeholders.
• Ensure submissions are scientifically sound and high quality.
• Monitor evolving regulatory requirements and impact on programs.
• Build relationships with authorities, consultants, contractors, and partners.
• Mentor junior regulatory professionals and contribute to process improvements.

Conocimientos

Regulatory strategy

Cross-functional leadership

Regulatory authority interactions

English fluency

Strategic thinking

Communication skills

Educación

Bachelor's in Life Sciences

Advanced degree (PharmD/MS/PhD/MBA) preferred

Descripción del empleo

Angitia Biopharmaceuticals seeks a Director, Global Regulatory Affairs to develop and execute global regulatory strategies for development programs. You will serve as the primary regulatory representative on cross-functional teams and provide strategic leadership across all phases of development.

You will partner with Clinical Development, Nonclinical, CMC, Safety, Biostatistics, and Operations to align regulatory strategy with business objectives, representing the company in interactions with