Apprentice - Regulatory Affairs

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're looking for people who are determined to make life better for people around the world.

Purpose:

The purpose of the Regulatory Affairs Apprentice role is to execute the operational aspects of regulatory affairs for a specific project, including:

• License variation activities related to the project (e.g. Labelling changes, CMC Changes)
• Tracking regulatory procedures and archiving correspondence in accordance with local regulations and quality system requirements.
• Provide operational excellence to successfully achieve Affiliate regulatory objectives. 
• Facilitate and cultivate relationships with relevant external regulatory personnel.

Primary Responsibilities:

Regulatory Plan Execution

• Collaborate with the implementation of the Regulatory Plan in alignment with specific project plans as well as with regulatory requirements.
• Support submission of high-quality regulatory applications within planned timelines.
• Support Dossier assembly in compliance with local regulations and quality system requirements. 

Regulatory Compliance

• Keep internal Regulatory IT tools up to date and accurate.
• Keep the regulatory archive complete and up-to-date and ensure that all current licenses and labels are affected by the project.
• Support implementation of local quality system in line with the global quality system and local regulations.
• Raise awareness on compliance issues with leadership and relevant functions. 

Labelling

• Ensure that Product Information complies with local regulatory requirements and that updated Product Information is submitted, approved and implemented within the designated internal and/or MOH timelines.
• Follow global labelling procedures and document relevant exceptions to produce accurate and high-quality Product Information which is following global core labeling.
• Provides support for product label implementations and ensure that IT tools up to date and accurate 

Process Improvement

• Support implementation of relevant internal regulatory initiatives.

Minimum Qualification Requirements:

Student of 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 and externally.
• Knowledge of Quality systems.

Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form ) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and 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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