Position: Entry level

Job type: Full-time

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Job content

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.

Purpose

The purpose of the Affiliate Regulatory Affairs (P1) role is to execute the operational aspects of regulatory affairs for the marketing affiliate, including:
  • License maintenance activities (e.g. Labelling changes, CMC Changes, Renewals)
  • New registrations, line extensions and new indications.
  • 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: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.

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 high quality regulatory applications within planned timelines.
    • Support dossier preparation of new applications to obtain marketing authorisations.
    • Coordinate administrative tasks (i.e. translations, legalizations, etc.) to facilitate dossier preparation.
    • Execute maintenance activities for marketing authorisations (timely submission of post approval maintenance activities like renewals, variations and periodic reports).
  • Support Dossier assembly in compliance with local regulations and quality system requirements.
  • 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 internal Regulatory IT tools up to date and accurate
  • Ensure that all products comply with local regulations and quality system requirements whichever is more stringent.
  • Keep the regulatory archive complete and up-to-date and ensure that all current licenses and labels are readily available
  • 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
  • Perform the function of Delegate or Alternate 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 MOH timelines.
  • Follow global labelling procedures and document relevant exceptions in order to produce accurate and high quality Product Information which is 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.
  • If available, attend external regulatory training or MoH meetings focusing on local regulations
Optional Responsibilities: This section is intended to provide additional responsibilities the position may require depending on the Affiliate structure and/or local requirements.

Patient Safety
  • Assist the Affiliate Pharmacovigilance Responsible Person in reporting received Adverse Events and submitting expedited and periodic safety reports to the Agency/MoH as per local regulations.
Product Quality
  • Assist the Product Quality Representative with the implementation and execution of Lilly Global Quality Standards in particular GQS-181/CQP-181 in the affiliate. Identify and support Product Quality tasks and, in collaboration with the Product Quality Representative, act as the local Quality contact.
  • Support the Product Complaint system as local Responsible Complaint person.
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 and externally.
  • Knowledge of Quality systems
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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