Senior Director Global Regulatory Lead (Early Phase) - Oncology
Eli Lilly and Company- Full Time
- Senior (5 to 8 years)
Candidates should possess a Bachelor’s degree in a scientific discipline, such as Pharmacy, Biology, Chemistry, or a related field, and hold a minimum of 8 years of experience in regulatory affairs, with at least 5 years in advertising and promotion, preferably within the pharmaceutical industry. Strong knowledge of FDA regulations, guidelines, and enforcement actions related to pharmaceutical advertising and promotion is essential, as is experience with Promotional Review Committee (PRC) processes. Demonstrated ability to manage complex regulatory interactions and provide strategic guidance is required, along with experience in leading cross-functional teams and mentoring junior colleagues.
The Associate Director, Regulatory Affairs Advertising and Promotion will manage the commercial regulatory strategy and execution for assigned brands or therapeutic areas, providing strategic regulatory guidance and input on Gilead’s commercial and corporate communications. They will serve as PRC Chair for complex brands, review and approve promotional materials, maintain awareness of FDA regulations and guidance, represent Gilead’s commercial regulatory perspective to regulatory agencies, lead local process improvements, provide regulatory guidance on new marketing concepts, and communicate relevant updates to cross-functional teams. Additionally, the role involves mentoring RA Ad/Promo and cross-functional team members, and potentially managing direct reports.
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.