Senior Regulatory Reporting Specialist

5 days ago

Indianapolis, Indiana, United States BioSpace, Inc. Full time
Job Summary

We are seeking a highly skilled and experienced Regulatory Reporting Specialist to join our team. In this role, you will be responsible for providing support across various regulatory reporting and inspection activities, including US FDA field alerts, global regulatory reporting, and support for global recall and US recall activities.

Key Responsibilities
  • Coordinate and execute regulatory reporting, including networking with CPQA, Global Quality Leaders, Senior Management, Legal, Global Patient Safety, Technical Services, Regulatory, Product Protection team, Lilly Security, and others as appropriate.
  • Provide information for use in various periodic reviews or metrics.
  • Monitor recall activities of partner organizations globally.
  • Support the coordination of the execution activities related to US product recall and withdrawals.
  • Participate in periodic product withdrawal/recall simulations.
Requirements
  • Bachelor's degree or equivalent experience in a scientific field such as Pharmacy, Chemistry, Engineering, or other biological sciences.
  • Minimum of 5 plus years relevant industry experience in areas which may include: technical services, manufacturing operations, quality assurance, quality control, or regulatory affairs.
  • Previous auditing experience.
  • Broad knowledge of GMPs and quality systems as they apply to pharmaceutical manufacturing and marketing.
  • Significant experience with deviation management and root cause analysis.
  • Experience in Quality Assurance or GxP function.
  • Strong compliance knowledge.
  • Demonstrated ability to communicate and deliver constructive feedback to customers, including excellent oral and written communication and oral presentation skills.
  • Ability to work independently and as part of a team with minimal supervision.
  • Experience with global compliance programs.
What We Offer

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.

Lilly is an EEO/Affirmative Action Employer and 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.

Our employee resource groups (ERGs) offer strong support networks for their members and help our company develop talented individuals for future leadership roles.

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