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

Regulatory Plan Execution

• Collaborate with the implementation of the Regulatory Plan in alignment with affiliate business plans as well as with

regulatory requirements.

• Support submission of regulatory applications within planned timelines as applicable.
  • Support dossier preparation of new applications to obtain marketing authorizations.
  • Coordinate administrative tasks (i.e. translations, legalizations, etc.) to facilitate dossier preparation.
  • Execute maintenance activities for marketing authorizations (timely submission of post approval maintenance activities like variations and periodic reports).
• Maintain awareness of current regulations and upcoming changes in the regulatory environment. Communicate changes to appropriate management and cross-functional experts as appropriate and implement locally.

Regulatory Compliance

• Keep the regulatory archive complete in regulatory systems as required.
• Support internal audits / assessments / self-inspections in collaboration with Regulatory Quality personnel.
• Raise awareness on compliance issues with leadership and relevant functions.

Labelling

• Perform the function of Delegate Affiliate Labelling Responsible Person (ALRP), ensuring that Product Information complies with local regulatory requirements and that updated Product Information is submitted, approved and implemented within the designated internal and/or HA timelines.
• Follow global labelling procedures in compliance with global core labeling.

Process Improvement

• Support implementation of relevant internal regulatory initiatives.

Personal and Professional Development

• Knowledge and understanding of local regulations and local, regional and global regulatory procedures.

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 ( https://careers.lilly.com/us/en/workplace-accommodation) 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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