Job Description
**Job Summary:** Regulatory Associate (RA) role in Global Regulatory Affairs (GRA) leads global marketing authorization submission management processes, partners with GRA-CMC Scientists, and provides guidance on structure and content placement within CTD registration submissions.
We are a global healthcare leader headquartered in Indianapolis, Indiana, with a diverse team of over 1,600 employees across 38 nationalities. Our employees work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism.
**Key Responsibilities:**
- Lead CMC submission management process by providing knowledge of CMC regulatory requirements, including ICH CTD and evolving global agency standards.
- Partner with CMC RA Scientist to plan and prepare submission content to support clinical studies and manufacturing process changes for development and marketed products.
- Drive the execution of submission planning for global registration and maintenance submissions.
- Triage Lilly affiliate inquiries and requests, and consult with CMC RA Scientist for guidance in preparing responses.
- Implement and interpret global regulations and guidance's, and look to regulatory precedence into submission processes and publishing standards.
**Requirements:**
- Bachelor's Degree in a scientific or health sciences discipline (e.g., pharmacy, chemistry, or related scientific discipline).
- Knowledge of pharmaceutical drug development or industry-related experience preferred.
- Ability to operate and manage operational requirements in a regulated environment.
- Written, spoken, and presentation skills.
- Negotiation and influence skills.
- Attention to detail and ability to effectively prioritize.
- Proven effective teamwork skills; able to adapt to diverse interpersonal styles.
We are committed to helping individuals with disabilities to participate in the workforce and ensure equal opportunity to compete for jobs. We do not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability, or any other legally protected status.