Director, Regulatory Affairs and Quality Assurance
OuraFull Time
Expert & Leadership (9+ years)
The Associate Director, Global Therapeutic Area (TA) Regulatory Liaisons should have experience in regulatory affairs, specifically within the Virology therapeutic area, and be responsible for supporting Gilead's strategic decisions for patient access to molecules. The role requires expertise in managing complex regulatory strategies, submissions, and lifecycle activities for products across the Intercontinental and Gilead Patient Solutions region, including Asia, Latin America, Africa, Eastern Europe, and the Middle East. Experience with HIV, Hepatitis, and/or Emerging Viruses projects is essential, along with a strong understanding of regulatory submissions and compliance.
The Associate Director will act as the Regional Regulatory Lead, overseeing and managing regulatory strategies for one or multiple products in the Virology TA. Responsibilities include shaping regulatory strategy, plans, and objectives, managing regulatory submissions and projects, and representing the regulatory affairs team on cross-functional teams. The role involves providing strategic and technical advice throughout the product lifecycle, overseeing the preparation and maintenance of regulatory submissions and labeling, and contributing to the development of regulatory strategies, processes, and capabilities. The Associate Director will also partner with internal regulatory affairs and cross-functional teams to ensure effective execution of regulatory strategies and build strong relationships.
Develops and commercializes biopharmaceuticals
Gilead Sciences focuses on discovering, developing, and commercializing medicines for various medical conditions, including HIV/AIDS, liver diseases, cancer, inflammatory and respiratory diseases, and cardiovascular issues. The company conducts extensive research and development to create new therapies, which are then marketed to healthcare providers, hospitals, and pharmacies after receiving regulatory approval. Gilead differentiates itself from competitors through its strong commitment to R&D and strategic partnerships, such as with SAP Ariba, to enhance its operations and product offerings. The company's goal is to improve health equity and access to care globally, working with communities to ensure that its medicines reach those in need.