Associate Director

For Current Gilead Employees and Contractors:
At Gilead, we’re creating a healthier world for all people. For more than 35 years, we’ve tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer - working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe. We continue to fight against the world’s biggest health challenges, and our mission requires collaboration, determination and a relentless drive to make a difference.

Every member of Gilead’s team plays a critical role in the discovery and development of life-changing scientific innovations. Our employees are our greatest asset as we work to achieve our bold ambitions, and we’re looking for the next wave of passionate and ambitious people ready to make a direct impact.

We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future, you are the key driver in evolving our culture and creating an environment where every employee feels included, developed and empowered to fulfil their aspirations. Join Gilead and help create possible, together.

**Job Description**:
At Gilead, we’re creating a healthier world for all people. For more than 35 years, we’ve tackled diseases such as HIV, viral hepatitis, COVID-19, and cancer - working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe. We continue to fight against the world’s biggest health challenges, and our mission requires collaboration, determination, and a relentless drive to make a difference.

Every member of Gilead’s team plays a critical role in the discovery and development of life-changing scientific innovations. Our employees are our greatest asset as we work to achieve our bold ambitions, and we’re looking for the next wave of passionate and ambitious people ready to make a direct impact.

We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future, you are the key driver in evolving our culture and creating an environment where every employee feels included, developed, and empowered to fulfil their aspirations. Join Gilead and help create possible, together.

About the role:
The Associate Director, Regulatory Affairs will play a key role in leading projects for the Regulatory Affairs team in the ANZ affiliate, working cross functionally to ensure Gilead complies with country’s applicable legislations and regulations linked to the MA / local license as MA Holder or as local legal representative of the MA Holder. Reporting to the Regulatory Head for ANZ, this role will work closely with cross-functional colleagues including Business Unit team members, Regulatory Affairs, Medical Affairs, Government Affairs, Public Affairs, Commercial & Trade Operations, Finance and out of country Global Value & Access.

Key Job Responsibilities:

- Contributes to the Vision and Direction for the RA organization at the country level in line with global/Regional RA and the local Affiliate Vision, and sets clear goals and objectives in line with the global Development Organization strategy
- Ensure that Gilead fulfills all relevant requirements linked to the MA / local license as MA Holder or as local legal representative of the MA Holder for the Affiliate
- Contributes to resource and budget planning and utilization
- Leads or provides input to the preparation of challenging regulatory submissions (initial MA Applications, line extensions, scientific advice, inspections, quality assurance related issues and risk management/minimisation activities) to local HA and leads or provides input to the interaction, negotiations and communication internally and externally, co-ordinates cross functional responses and act as the main point of contact for the local HA
- Lead or support country/national scientific advice and / or pre-submission meeting preparation and follow-up
- Lead or provide Affiliate input to the International and global regulatory strategy, upon request, including input into clinical development programmes
- Initiates local improvements and contributes to local and/or global process improvements which have a significant impact for RA and other departments, assesses proposed changes to local procedural documents, sharing of best practice and impact on existing processes
- Responsible for promotional material review and approval, certifies materials where appropriate
- May act as the local Gilead representative as required by local law or supervises these individuals e.g. Qualified Person QA, QPPV, Responsible Person PV, RP QA etc
- Leads or provide Affiliate input to risk assessments on major local regulatory issues and changes, and develops mitigation strategies as required
- A regulatory expert in updating and preparing the Company for major changes in r