Associate Director - Regulatory Affairs

For Current Gilead Employees and Contractors:

Please log onto your Internal Career Site to apply for this job.

At Gilead were creating a healthier world for all people. For more than 35 years weve tackled diseases such as HIV viral hepatitis COVID19 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 worlds biggest health challenges and our mission requires collaboration determination and a relentless drive to make a difference.

Every member of Gileads team plays a critical role in the discovery and development of lifechanging scientific innovations. Our employees are our greatest asset as we work to achieve our bold ambitions and were 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 were creating a healthier world for all people. For more than 35 years weve tackled diseases such as HIV viral hepatitis COVID19 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 worlds biggest health challenges and our mission requires collaboration determination and a relentless drive to make a difference.

Every member of Gileads team plays a critical role in the discovery and development of lifechanging scientific innovations. Our employees are our greatest asset as we work to achieve our bold ambitions and were 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 countrys 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 crossfunctional 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 coordinates cross functional responses and act as the main point of contact for the local HA
• Lead or support country/national scientific advice and / or presubmission meeting preparation and followup
• Lead or provide Affiliate input to the International and global regulatory strategy upon request including input into clinical development programmes
• Ensures compliance with local law and regulation and consistency with global procedural documents including Quality Assurance matters such as acting as a subject matter expert or audit / inspection lead within the affiliate ensuring essential licenses contracts and agreement are in place and falsified/counterfeit products stock outs and recalls are managed optimally.
• 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 regulatory legislation and competitor information in the country contributes to guideline and regulation development and develops strategies to optimize the outcome
• Leads or provides Affiliate input as an ambassador for RA and Development Organization at internal and external meetings or working parties building recognition as a thought leader
• Mentoring training and coaching regulatory and nonregulatory staff as required

Knowledge & Skills

• Leadership skills showing the ability to influence externally crossfunctionally and within global RA
• Vision and direction setting
• Extensive experience working with local HA at a senior level
• Must be capable of developing and implementing regulatory strategies and/or managing complex discussions with the local HA
• Experienced leader of projects and teams
• Good people management and development experience
• Strong cross functional internal and external network
• Experienced influencer negotiator and decision maker
• Good decision making and prioritization skills are important
• Excellent verbal and written English language skills organization skills and interpersonal communication skills required

What you will bring to the role

• 12 years of experience in RA or other relevant industry experience with BS/BA or 10 years of experience in RA or other relevant industry experience with advanced degree. Degree in a scientific field is preferred
• Excellent knowledge and proven experience in understanding and implementing regulatory requirements in Pharmaceutical / Biotech Industry including ICH requirements and regional requirements and have an understanding of current trends in the local affiliate
• Experienced in developing and implementing complex regulatory strategy and managing challenging negotiations with a HA
• Strong knowledge of quality assurance promotional and nonpromotional review as well as pharmacovigilance and market access
• Very experienced in working and leading crossfunctional project teams
• Strong people management experience
• Excellent working knowledge regarding country/national and regional HAs and the local Trade Association recognized as a thought leader by both organizations. Excellent knowledge of developing trends in the local rules and regulations and the potential impact to the organization

Gilead Leadership Commitments

You will be a role model of the Gilead Leadership Commitments which are five principles that articulate clear expectations for behaviours and mindsets of all Gilead employees. The Leadership Commitments includeI Am Bold I Care I Listen I TrustandI Own.

Commitment To Diversity and Inclusion

We want all our employees to embrace and leverage each others talents and diverse perspectives foster a sense of belonging achieve their full career potential and contribute to the teams success. This is demonstrated through our Bronze Status in the Australian Workplace Equality Index.

As an equal opportunity employer Gilead Sciences is committed to a diverse workforce. Employment decisions regarding recruitment and selection will be made without discrimination based on race colour religion national origin gender age sexual orientation physical or mental disability genetic information or characteristic gender identity and expression veteran status or other nonjobrelated characteristics or other prohibited grounds specified in applicable federal state and local laws.

As a company committed to reconciliation we welcome and encourage applications from people of Aboriginal and Torres Strait Islander descent.

For Current Gilead Employees and Contractors:

Please log onto your Internal Career Site to apply for this job.