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 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\xe2\x80\x99re looking for people who are determined to make life better for people around the world.

Purpose

The purpose of the role is to execute the operational aspects of regulatory support on Lilly\xe2\x80\x99s behalf for the strategic business partners who are Marketing Authorization Holders for Lilly products in the ASEAN region, including:

• Partner Oversight: Provide operational excellence to support submission plans, assist to monitor progress and provide Lilly support as necessary
• Dossier Management: Support timely provision of required submission documents to the Partners as per agreed submission plans. Maintain data in Lilly systems and electronic archives
• Support labelling projects to ensure new and updated printed packaging materials are available in line with timelines agreed with the Partner

Primary Responsibilities

Partner Oversight

• Keep track of submission plans and follow-up on progress of submission/timelines with assigned Partner(s)
• Serve as affiliate regulatory point person for queries from global functions (Global Regulatory Affairs, Quality, Supply Chain, Manufacturing)
• Conduct routine oversight and keep track of performance metrics, via regular interactions with the Partner(s)
• Archive External Party Management documentation

Regulatory Planning

• Collaborate with Partners to ensure timely and clear dossier requirements are provided to Lilly support groups during submission planning
• Maintain submission plan in systems and update on monthly basis based on information from Partner
• Support implementation of the Regulatory Plan in alignment with Lilly and Partner business plans

Dossier Management

• Work with global Lilly functions to obtain all required submission documents and timely responses to Regulatory Authority requests received from the Partner
• Provide submission documents to Partner as per agreed timelines
• Archive electronic copies of applications

Regulatory Compliance

• Maintain internal Regulatory IT tools up to date and accurate.
• Support implementation of local quality system in line with the global quality system and local regulations.
• Support internal audits / assessments / self-inspections in collaboration with Regulatory Quality personnel.
• Raise awareness on compliance issues with leadership and relevant functions.

Labelling

• Ensuring that Product Information complies with Lilly Core Data Sheet.
• Follow global labelling procedures to review Proposed Labelling for exceptions to Core Labelling and ensure all such exceptions are documented
• Create labelling projects and liaise with Supply Chain and Packaging Department to ensure new/revised labelling available in line with Partner\xe2\x80\x99s timelines

Process Improvement

• Support implementation of relevant internal regulatory initiatives.

Personal and Professional Development

• Knowledge and understanding of local and regional regulations and local, regional, and global regulatory procedures.
• Develop Subject Matter Expertise in one or more key areas of Regulatory Affairs (CMC, Labelling etc)
• If available, attend appropriate external regulatory training

Minimum Qualification Requirements:

• Bachelor\'s degree or equivalent in a relevant scientific subject (or partial completion of a relevant degree for a training position)
• Good communication skills
• Demonstrated good computer/IT skills.
• Good knowledge of written and spoken English.

Other Information/Additional Preferences:

• Ability to adapt to difficult and different challenges
• Team working skills with special focus on results
• Time management skills
• Good capability to establish positive networking both internally.
• Knowledge of quality systems

Eli Lilly and Company, Lilly USA, LLC and our wholly owned subsidiaries (collectively \xe2\x80\x9cLilly\xe2\x80\x9d) 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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