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, 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 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 life-changing 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 roleLeads the Australia/New Zealand Affiliate Regulatory Affairs functionRegulatory lead on the Australia/New Zealand Affiliate leadership team representing Regulatory Affairs (RA), as well as the broader Development OrganizationAffiliate lead on the regional RA leadership teamLead cross functional business partnering, as requiredLead Affiliate regulatory representative and senior representative of Development Organization at internal and external meetingsEnsures that Gilead complies with countrys applicable legislations and regulations linked to the Marketing Authorization (MA)/ local license as MA Holder or as local legal representative of the MA HolderEnsures that the medicinal products in the region can be developed, authorized and maintained on the marketServes as a core member or leads cross functional project teams regionally, Internationally or globallyMember of extended leadership teams, operational groups or leadership communities, as requiredDeputises for senior management as and when requiredKey ResponsibilitiesProvides 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 strategyRegulatory lead on the Australia/New Zealand leadership team providing cross functional support and strategic adviceEnsure 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 regionCrisis management functional lead in the regionUltimately responsible for regional resource and budget planning and utilizationLead communicating important changes to the regional, international and global Regulatory and Development Organization function/activitiesManages 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 rolesOversees all regulatory activities in Australia/New Zealand, acts as strategic advisor or lead on very complex or challenging issuesAdvises Reg Heads on country/national scientific advice and / or pre-submission meeting preparation and follow-up challengesInput to the International and global regulatory strategy, upon request, including input into clinical development programmesEnsures compliance with local law and regulation and consistency with global procedural documents for all aspects of regional Affiliate Regulatory workLeads or serves as a core member on regional, international and global improvements, initiatives and taskforcesExpert advisor to international and local promotional material review teamsExpert 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 teamsActs as an expert to local Affiliate, regional, Intl or Global RA teams on Affiliate mattersLeads risk assessments on critical or major regulatory issues and changes in the region, and develops mitigation strategies as requiredA 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 outcomeLeads and is an ambassador for RA and the Development Organization at internal and external meetings or working parties building recognition as a thought leaderOversee work in additional countries e.g. distributor markets as requiredMentoring, training and coaching regulatory and non-regulatory staffKnowledge & SkillsExpert leadership skills showing the ability to influence externally, cross-functionally and within global Development Organization and RAExcellent compelling vision and direction settingExtensive experience working with multiple local HA and Trade Association at a senior levelExpert in developing and implementing regulatory strategies and managing challenging discussions with the local HAExcellent leader of complex cross functional projects and teamsExpert people management and development experienceExtensive productive cross functional internal and external networksExpert influencer, negotiator and decision makerExcellent decision making and prioritization skills are importantExcellent verbal and written English language skills, organization skills and interpersonal communication skills requiredEducation & Experience16+ 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 preferredExpert 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 affiliateExpert in developing and implementing very complex regulatory strategy and managing challenging negotiations with a HAExcellent knowledge of quality assurance, promotional and non-promotional review as well as pharmacovigilance and market accessExpert in working and leading cross-functional project teamsExcellent people management experienceExpert 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 organizationGilead Leadership CommitmentsYou 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 InclusionWe 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 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. #J-18808-Ljbffr
Job Title
Senior Director / Director - Regulatory Affairs ANZ