Global Therapeutic Area (TA) Regulatory Liaisons - Manager

The position is within the Virology IC/GPS (Intercontinental and Global Patient Solutions) Franchise, working across territories throughout Asia, Latin America, Africa, Eastern Europe and the Middle East. You will work within the global team and closely with local teams to define the regulatory strategy, plans and objectives for assigned products or projects. You will manage regulatory submissions and other projects, representing the IC/GPS regulatory franchise on cross-functional core and sub-teams. You will act as the Regional Regulatory Lead on products in the virology therapeutic area covering HIV, Hepatitis and Emerging Viruses projects/products. You will typically be assigned multiple products or projects to lead, manage and oversee simultaneously. You will provide strategic and technical advice from development throughout the whole product lifecycle. You will prepare and maintain regulatory submissions, regulatory labelling and packaging for assigned products or projects; guide and advise other colleagues in the thorough and compliant completion of these activities. You will work cross-functionally with a diverse number of stakeholders both internally and externally to Gilead.,

• Responsible for managing and leading regulatory strategies for designated products in the region. This ranges from new product licenses to lifecycle activities and includes oversight of all regulatory aspects of the application.
• Responsible for the preparation of regulatory submissions for products in the virology therapeutic area and execution of agreed strategies within the region.
• Partner both within regulatory affairs and throughout the development and commercial organization. Collaborate with cross-functional partners to ensure optimal execution of the agreed regulatory strategy.
• Establish strong relationships with Gilead affiliates and distributor partners and serve as point person for knowledge for their product to these key stakeholders.
• Have a good understanding of the regulatory environment leveraging internal knowledge and external regulatory intelligence.
• Responsible for the preparation and maintenance of labelling to support MAAs and other post-licensing activities. Ensure that any updates to the Product Company Core Data Sheet (CCDS) are implemented in a timely manner.
• Liaise with regulatory, manufacturing, and other parties as appropriate, to ensure that updates to the product packaging components are implemented in line with approved labelling in line with agreed timelines.
• Participate and contribute to regulatory team meetings and be recognized as a knowledgeable resource for Regulatory Affairs in other departments.
• May participate and lead collaborative efforts across function in process improvement initiatives.
• Use internal electronic systems for planning, preparing, tracking and storing submissions to regulatory agencies.
  
  BA/ BS or advanced degree in life sciences or related field with regulatory experience in the biopharma industry, regulatory agency, clinical research or other related healthcare environment. Experience a broad range of regulatory activities and setting the regulatory strategy for biopharmaceutical products.
Knowledge & Other Requirements
• A good working regulatory knowledge, including ICH and regional requirements.
• An appreciation of current global and regional trends in Regulatory Affairs with proven effectiveness in applying this knowledge to optimize team deliverables.
• Previous experience of working with emerging markets and/or in the Virology therapeutic area would be an advantage but not essential.
• Methodical attention to detail.
• Must have a "can do" attitude and be "hands on" as and when required.
• Proven track record to manage, formulate and execute strategy.
• Strong interpersonal skills and understanding of team dynamics.
• Strong communication and organizational skills.
• Strong negotiation and conflict resolution skills.
  
  Gilead Sciences, Inc. Global Therapeutic Area (TA) Regulatory Liaisons - Manager in Cambridge, United Kingdom
For Current Gilead Employees and Contractors: Please log onto your Internal Career Site (https://www.myworkday.com/gilead/d/inst/13102!CK5mGhIKBggDEMenAhIICgYI1A0QtgI/cacheable-task/2997$2151.htmld#backheader=true) to apply for this job. 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., Gilead Sciences, Inc. is a biopharmaceutical company that has pursued and achieved breakthroughs in medicine for more than three decades, with the goal of creating a healthier world for all people. The company is committed to advancing innovative medicines to prevent and treat life-threatening diseases, including HIV, viral hepatitis and cancer. Gilead operates in more than 35 countries worldwide, with headquarters in Foster City, California.