Job Description

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our 35,000 employees around the world 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. We give our best effort to our work, and we put people first. We're looking for people who are determined to make life better for people around the world.

RA Specialists - Japan Regulatory Operations

The purpose of the role of Japan Regulatory Operations -Lilly Capability Centre India (LCCI) is to provide operational and technical support according to the request to enable all regulatory affairs activities in Japan.

This job description is intended to provide a general overview of the job requirements at the time it was prepared. The job requirements of any position may change over time and may include additional responsibilities not specifically described in the job description. Consult with your supervision regarding your actual job responsibilities and any related duties that may be required for the position.

Assistance with regulatory affairs using Lilly's internal systems.

• Operational support, including registration and management of files and information in the system.
• Support for operations using information in the system.

Operational document support

• Maintenance of the appearance of Japanese documents based on the style guide.
• Drafting of the standardized regulatory materials.

Other general support for Japan regulatory affairs' works to compliance with the Pharmaceutical and Medical Device Act (PMD Act) and related regulations

Ensure compliance to quality system documents, local laws and regulations and training requirements.

Minimum Qualification Requirements:

• Good verbal (conversational level) and written communication in Japanese. Preference will be given to JLTP passed candidates.
• Native or equivalent level of English.
• Good project management skills with ability to prioritize and handle multiple deliverables simultaneously.
• Bachelor's degree or equivalent work experience for more than one year, in healthcare, scientific field or business background
• Proficiency in basic use of Microsoft applications (Word, Excel, PowerPoint etc.), adobe acrobat and computer systems/database
• Ability to collaborate and work across different time zones/geographies interacting with diverse individuals and teams.

Other Information/Additional Preferences:

• Work experiences in pharmaceutical companies, especially in regulatory affairs (development regulatory, Labeling, preclinical or CMC) and/or drug development.
• Understanding of regulations and guidelines that apply to drug development.

Eli Lilly and Company, Lilly USA, LLC and our wholly owned subsidiaries (collectively "Lilly") are committed to help individuals with disabilities to participate in the workforce and ensure equal opportunity to compete for jobs. If you require an accommodation to submit a resume for positions at Lilly, please email Lilly Human Resources ( Lilly_Recruiting_Compliance@lists.lilly.com ) for further assistance. Please note This email address is intended for use only to request an accommodation as part of the application process. Any other correspondence will not receive a response.

Lilly does 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.

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