Lilly Jobs

Job Information

Lilly Senior Regulatory Affairs Associate in West Ryde, Australia

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.

  • In 2021, Lilly Australia has been recognised as one of the best places to work at the Australian HR Awards.

  • In 2021, Lilly Australia is a finalist at the highly recognised PRIME Awards for excellence in patient and customer support programs

Whoever you are, wherever you’re from, if you want to make life better for people around the world, you belong at Lilly.

The purpose of the Affiliate Regulatory Affairs role is to manage the operational and technical aspects of regulatory affairs for the affiliate, including:

  • execute the Regulatory Plan to ensure the success of new product registrations, 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

  • facility and cultivate relationships with the local regulatory agencies.

Responsibilities:

  • execute Regulatory Plan in alignment with affiliate business plans as well as regulatory requirements for a portfolio of products

  • ensure timely submission and approval of high quality regulatory submissions for new registrations, new indications, line extensions

  • support affiliate Launch Teams to support affiliate launch plans

  • represent Regulatory Affairs as appropriate in Lead Team and New Product Planning discussions

  • maintain product and manufacturing site registrations for existing registrations

  • ensure regulatory compliance with internal and external requirements

Basic Requirements:

  • Bachelor's degree or equivalent in a relevant scientific subject

  • at least 3 years industry related experience in regulatory affairs and experience of dealing with external regulatory agencies, the healthcare system and marketing needs

  • team working skills with special focus on results

  • ability to adapt to challenging situations

  • demonstrated good computer/IT skills

  • good knowledge of written and spoken English

Additional Skills/Preferences:

  • analytical, problem solving and negotiation skills

  • good communication skills

  • project management skills

  • strong planning and priority setting

  • good capability to establish positive networking both internally (locally, regionally and globally) and externally

  • strong knowledge of quality systems

As a condition of employment with Eli Lilly Australia and Eli Lilly New Zealand, you must be fully COVID-19 vaccinated and provide proof of vaccination satisfactory to the company. If you would like to request an exemption on medical or other grounds, you may do so by emailing ANZ_HR@lilly.com

Life at Lilly:

We are committed to investing in our employees, through competitive salaries, development and training, generous benefits, and the opportunity to make an impact on the world.

Our total rewards programs are designed for your overall well-being, supporting you wherever you are in your life and career journey- offering flexibility and choice to help you be the best you. We grow and lead at all levels of the company, where unleashing your potential means exploring cutting-edge solutions and investing in your development, no matter what job, title, or tenure you have.

Whoever you are, wherever you’re from, if you want to make life better for people around the world, you belong at Lilly.

Learn more at www.lilly.com.au

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 ( LillyRecruitingCompliance@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.

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

DirectEmployers