Senior Regulatory Affairs Associate

3 weeks 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 work to discover and bring life-changing medicines to those in need, improve the understanding and management of disease, and give back through philanthropy and volunteerism. We prioritize our work and put people first. We're looking for individuals committed to making life better globally.

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:

  • Executing the Regulatory Plan to ensure successful registration of new products, line extensions, and new indications in line with the affiliate business plan, while maintaining compliance with local regulations and quality system requirements.
  • Fostering operational excellence and collaborating with cross-functional teams to achieve regulatory objectives.
  • Facilitating and cultivating relationships with local regulatory agencies and the Ministry of Health.

Primary Responsibilities:

  1. Regulatory Plan Execution
  2. Regulatory Compliance
  3. Labelling
  4. Process Improvement
  5. Personal and Professional Development

Lilly is dedicated to helping individuals with disabilities actively engage in the workforce and ensuring equal opportunities. If you require accommodation to submit a resume, please complete the workplace accommodation request form. This request is for application process accommodations only; other correspondence will not receive a response.

Lilly does not discriminate based on 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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