Associate/Manager - Regulatory Project Management and Operations

$61,500 - $143,000/Yr

Eli Lilly - Indianapolis, IN

Full-time - Mid Level

Remote - Indianapolis, IN

Chemical Manufacturing

About the position

The Manager, Regulatory Operations and Project Management at Lilly is responsible for supporting Regulatory Leads and cross-functional program teams in the preparation and maintenance of global regulatory submissions. This role plays a pivotal part in implementing regulatory systems and processes to enhance regulatory process improvement, ensuring that the company continues to deliver life-changing medicines effectively.

Responsibilities

• Manage the preparation and maintenance of global regulatory submissions in partnership with Regulatory Leads and cross-functional teams.
• Effectively monitor and communicate the progress of regulatory projects to relevant stakeholders.
• Support the authoring of regulatory dossier documents with guidance from Regulatory Leads.
• Implement and oversee systems for maintaining and tracking regulatory information, including archives of regulatory submissions, correspondence, and commitments.
• Proactively develop solutions to remove barriers and maintain project deliverables.

Requirements

• Bachelor's Degree in life science or related scientific discipline.
• 1-3+ years of related work experience in regulatory affairs, regulatory operations, and/or project management.

Nice-to-haves

• Excellent organizational, communication, and project management skills.
• Demonstrated ability to work well in a collaborative and dynamic team environment, set priorities, and drive results.
• Highly proficient in Microsoft and project management applications.
• Working knowledge of eCTD publishing systems, regulatory/document management systems, and related tools.
• Previous eCTD filing experience and a clear understanding of global regulatory submission content and format requirements, as well as the interdependencies between submission components.
• Excellent document drafting, editing, and proofreading skills, with high attention to detail.
• A collaborative team player with a 'can do' attitude and an eagerness to grow and apply their regulatory knowledge.

Benefits

• Health insurance
• Dental insurance
• 401(k)
• Flexible spending account
• Employee assistance program
• Vision insurance
• Life insurance