Remote Associate Director, Regulatory Programs

Eli Lilly; United States; A distancia; USD 137.000 - 220.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Remote work in US

Comprehensive benefits package

Descripción de la vacante

Lilly in the United States is seeking an Associate Director, Regulatory Project Management to lead regulatory submissions and cross-functional plans across IND, NDA, BLA, and MAA activities. Based in the US with a remote-work option and occasional travel, you will coordinate clinical, nonclinical, CMC and quality teams, manage timelines, and report risks to leadership.

A bachelor’s in a scientific field and 8+ years regulatory experience are required; compensation ranges from $136,500 to

Formación

• Bachelor’s degree in a scientific or related field.
• 8+ years of industry based regulatory experience.
• Strong understanding of regulatory frameworks and compliance requirements in relevant industries.
• Proficiency in project management tools (Microsoft Project, Smartsheet) and methodologies (PMP, PRINCE2, RAC).
• Excellent interpersonal and communication skills to engage stakeholders, facilitate meetings, and drive decision-making.
• Analytical and problem-solving abilities to interpret regulatory requirements and translate them into actionable project tasks.
• Attention to detail is important for preparing accurate documentation and maintaining regulatory compliance.

Responsabilidades

• Develop and maintain plans for regulatory submissions (IND, NDA, BLA, MAA) and post-approval work.
• Coordinate timelines with Clinical, Nonclinical, CMC, Quality and Commercial teams.
• Identify and mitigate risks; create contingency plans to meet milestones.
• Lead interactions with global health authorities and agency meetings.
• Oversee authoring and review of submission dossiers for accuracy.
• Track budgets, forecast expenditures, and report financial performance.

Conocimientos

Regulatory knowledge

Project management

Stakeholder engagement

Communication

Attention to detail

Educación

Bachelor’s degree in a scientific or related field

Herramientas

Microsoft Project

Smartsheet

Descripción del empleo

Lilly in the United States is seeking an Associate Director, Regulatory Project Management to lead regulatory submissions and cross-functional plans across IND, NDA, BLA, and MAA activities. Based in the US with a remote-work option and occasional travel, you will coordinate clinical, nonclinical, CMC and quality teams, manage timelines, and report risks to leadership.

A bachelor’s in a scientific field and 8+ years regulatory experience are required; compensation ranges from $136,500 to