Regulatory Affairs Liaisons Manager- Global Therapeutic Area (TA)

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.

POSITION OVERVIEW: The global regulatory affairs team is responsible for supporting Gilead to make sound strategic decisions to enable access for patients to our molecules. The position is in the Virology IC/GPS regulatory franchise which is responsible for Intercontinental and Gilead Patient Solutions, working across territories throughout Asia, Latin America, Africa, Eastern Europe and the Middle East. Working within the global team, you will support defining the regulatory strategy, plans and objectives for assigned products or projects. Your responsibilities will involve managing regulatory submissions and other projects, representing the IC/GPS regulatory franchise on cross-functional core and sub-teams. As a Regional Regulatory Lead of products in the virology therapeutic area 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 for all HIV, Hepatitis and Emerging Viruses projects/products. Activities will include preparing and maintaining regulatory submissions, regulatory labelling and packaging for assigned products or projects; guiding and advising 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.

EXAMPLE RESPONSIBILITIES:

• 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.
• 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.
• 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.

REQUIREMENTS: We are all different, yet we all use our unique contributions to serve patients. Please see the following for the qualifications and skills we seek for this role.

• Education & Experience: 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.