Senior Regulatory Affairs Associate at Lilly

Sydney, New South Wales, Australia -

Full Time

Start Date

Immediate

Expiry Date

10 Jun, 26

Salary

0.0

Posted On

12 Mar, 26

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Regulatory Plan Execution, Regulatory Compliance, Labelling, Process Improvement, Product Registration, Line Extensions, New Indications, Local Regulations, Quality System Requirements, Cross-functional Collaboration, Agency Relationship Management

Industry

Pharmaceutical Manufacturing

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. 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 (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. #WeAreLilly At Lilly we strive to ensure our employees are part of a team that cares about them and our shared purpose of making life better for those around the world. How do we do this? We continue to look for ways to include, innovate, accelerate and deliver while maintaining integrity, excellence and respect for people. We hope that you seek to join us on our journey as we create medicine and deliver improved outcomes for patients across the globe! #WeAreLilly

Responsibilities

The role involves managing the operational and technical aspects of regulatory affairs for the marketing affiliate, including executing the Regulatory Plan for new product registrations, line extensions, and new indications while ensuring compliance with local regulations. This includes fostering operational excellence and collaborating with cross-functional teams to meet affiliate regulatory objectives.