Senior Director

Senior Director / Director - Regulatory Affairs ANZ Australia - Melbourne 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 Leads the Australia/New Zealand Affiliate Regulatory Affairs function Regulatory lead on the Australia/New Zealand Affiliate leadership team representing Regulatory Affairs (RA), as well as the broader Development Organization Affiliate lead on the regional RA leadership team Lead cross-functional business partnering, as required Lead Affiliate regulatory representative and senior representative of Development Organization at internal and external meetings Ensures that Gilead complies with country's applicable legislations and regulations linked to the Marketing Authorization (MA)/ local license as MA Holder or as local legal representative of the MA Holder Ensures that the medicinal products in the region can be developed, authorized and maintained on the market Serves as a core member or leads cross-functional project teams regionally, Internationally or globally Member of extended leadership teams, operational groups or leadership communities, as required Deputises for senior management as and when required Key Responsibilities Provides the Vision and Direction for the RA organization in Australia/New Zealand in line with global/Regional RA Development Organization and Commercial Visions and sets clear goals and objectives in line with the Development Organization strategy Regulatory lead on the Australia/New Zealand leadership team providing cross-functional support and strategic advice 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 region Crisis management functional lead in the region Ultimately responsible for regional resource and budget planning and utilization Lead communicating important changes to the regional, international and global Regulatory and Development Organization function/activities Manages Australia/New Zealand Reg Affiliate team and leads the Regulatory activities, is responsible for the Australia/New Zealand regulatory teams deliverables, professional development and putting in place succession plans for critical roles Oversees all regulatory activities in Australia/New Zealand, acts as strategic advisor or lead on very complex or challenging issues Advises Reg Heads on country/national scientific advice and / or pre-submission meeting preparation and follow-up challenges 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 for all aspects of regional Affiliate Regulatory work Leads or serves as a core member on regional, international and global improvements, initiatives and taskforces Expert advisor to international and local promotional material review teams Expert advisor to local Gilead representative as required by local law e.g.
Qualified Person QA, QPPV, Responsible Person PV, RP QA, etc and the respective regional functional teams Acts as an expert to local Affiliate, regional, Intl or Global RA teams on Affiliate matters Leads risk assessments on critical or major regulatory issues and changes in the region, and develops mitigation strategies as required A regulatory expert in updating and preparing the Company for major changes in regulatory legislation and competitor information, contributes to guideline and regulation development and develops strategies to optimize the outcome Leads and is an ambassador for RA and the Development Organization at internal and external meetings or working parties building recognition as a thought leader Oversee work in additional countries eg distributor markets as required Mentoring, training and coaching regulatory and non-regulatory staff Knowledge & Skills Expert leadership skills showing the ability to influence externally, cross-functionally and within global Development Organization and RA Extensive experience working with multiple local HA and Trade Association at a senior level Expert in developing and implementing regulatory strategies and managing challenging discussions with the local HA Excellent leader of complex cross-functional projects and teams Expert people management and development experience Extensive productive cross-functional internal and external networks Expert influencer, negotiator and decision maker Excellent decision making and prioritization skills are important Excellent verbal and written English language skills, organization skills and interpersonal communication skills required Education & Experience 16+ years of experience in RA or other relevant industry experience with BS/BA or 14+ years of experience in RA or other relevant industry experience with advanced degree.
Degree in a scientific field is preferred Expert diverse knowledge and proven experience in understanding and implementing regulatory requirements in Pharmaceutical / Biotech Industry, including ICH requirements and international requirements and have an understanding of current trends in the local affiliate Expert in developing and implementing very complex regulatory strategy and managing challenging negotiations with a HA Excellent knowledge of quality assurance, promotional and non-promotional review as well as pharmacovigilance and market access Expert in working and leading cross-functional project teams Expert working knowledge of country/national and regional HAs and the local Trade Associations, recognized as a thought leader.
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 include I Am Bold, I Care, I Listen, I Trust, and I Own .
Commitment To Diversity and Inclusion We want all our employees to embrace and leverage each other's talents and diverse perspectives, foster a sense of belonging, achieve their full career potential, and contribute to the team's 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 non-job-related 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.
Job Requisition ID: R0044143 Job Level: Director Full Time/Part Time: Full-Time #J-18808-Ljbffr

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