Senior Regulatory Affairs Associate

6 days ago

Sydney, New South Wales, Australia Eli Lilly and Company Full time

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.

Role
The purpose of the Senior Associate, GRA Regional Regulatory, Affiliate (P2) role is to manage the operational and technical aspects of regulatory affairs for the marketing affiliate, including:

  • Execute the Regulatory Plan to ensure the success of new product registration, line extensions and new indications in alignment with the affiliate business plan, while maintaining compliance for all products with local regulations and

quality system requirements.

  • Foster an environment of operational excellence and collaborate with cross-functional teams to successfully

achieve Affiliate regulatory objectives.

  • Facilitate and cultivate relationships with the local regulatory agency/MoH.

Primary Responsibilities

  • Regulatory Plan Execution
  • Regulatory Compliance
  • Labelling
  • Process Improvement
  • Personal and Professional Development

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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