Pharma R&D Regulatory Affairs Manager

The TeamAI & Data is an integrated team of data and AI technologists working across Operate, AI, and Engineering. We serve as a trusted advisor and managed service provider bringing a mix of capability and capacity across data modernization, data ops, AI, and ML. Through our unrivaled breadth and depth of services across every major industry and domain, we help our clients run smarter, faster, and more efficiently. With Deloitte's AI & Data, our clients have the support they need to continuously develop, innovate, automate, scale, and operate in service of organizational performance and growth.Recruiting for this position will end on 12/11/2024.Work You'll DoAbout LSHCThroughout the health ecosystem, you'll find courageous and inspiring people who are committed to driving transformation, advancing health equity, and leading a well-being revolution. Where you find innovators committed to sustainable progress, you'll find Deloitte's Life Sciences & Health Care practice. Our leaders work side-by-side to orchestrate and deliver on the business of science and health. We bring trusted, flexible approaches that foster innovation, harness new technologies, and formulate consumer-driven strategies to engineer a digitally enabled, equitable future of health - starting today.Life SciencesAcross life sciences you'll find innovators who are developing therapies, treatments, devices, and cures to meet society's most pressing health challenges and deliver wellness for all. Alongside them, you'll find our leaders, the professionals of Deloitte's Life Sciences practice, who are orchestrating and delivering the business of science and health. We help drive impact through deep industry experience and insights; transformative strategies; trusted, flexible approaches; and new technologies. We help accelerate action and create connections that empower a digitally enabled, equitable future of healthAs a Manager you will lead and deliver small engagements, or components of large, complex engagements that identify, design and implement creative business and technology solutions for our clients. Using a combination of direct management and hands-on delivery, you will craft solutions for clients, guide and oversee the quality of your team's deliverables and recommendations, as well as manage day-to-day stakeholder relationships. Managers also contribute to Deloitte's thought leadership, play a significant role in business development activities (to include, the development and presentation of proposals), and own responsibility for the development of junior staff.QualificationsRequired:• 6+ years experience with relevant consulting experience.• 4+ years of Life Sciences industry experience in the Pharmaceutical R&D regulatory affairs function to include:• Experience introducing new technologies such as GenAI/AI/ML and automation for pharmaceutical regulatory content or regulatory intelligence• Understanding of pharmaceutical regulatory data and regulatory filing requirements• Experience with pharmaceutical regulatory operating model transformations• Experience with regulatory digital transformations / innovations• Experience with submissions management, labeling, CMC change control and/or LCM processes• Knowledge around generating pharmaceutical submissions packages• Experience with Veeva RIM and/or QMS implementations• 1+ years experience leading, managing and delivering complex engagements with resources in multiple locations• Bachelor's Degree• Ability to travel up to 50% on average, based on the work you do and the clients and industries/sectors you serve• Limited immigration sponsorship may be availablePreferred:• Ability to orchestrate, lead, and influence virtual teams, ensuring successful implementation of customer projects• Presentation skills with a high degree of comfort with both large and small audiences• Demonstrated experience driving both the sales cycle by taking the lead in framing out client opportunities and leading the pursuit team to create the proposal content for client discussions• Strong problem solving and troubleshooting skills with the ability to exercise mature judgment• Demonstrated experience with management and delivery of multiple strategic engagements for large global organizationInformation for applicants with a need for accommodation: https://www2.deloitte.com/us/en/pages/careers/articles/join-deloitte-assistance-for-disabled-applicants.htmlThe wage range for this role takes into account the wide range of factors that are considered in making compensation decisions including but not limited to skill sets; experience and training; licensure and certifications; and other business and organizational needs. The disclosed range estimate has not been adjusted for the applicable geographic differential associated with the location at which the position may be filled. At Deloitte, it is not typical for an individual to be hired at or near the top of the range for their role and compensation decisions are dependent on the facts and circumstances of each case. A reasonable estimate of the current range is $144,600 to $241,000.You may also be eligible to participate in a discretionary annual incentive program, subject to the rules governing the program, whereby an award, if any, depends on various factors, including, without limitation, individual and organizational performance.AI&DE25All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability or protected veteran status, or any other legally protected basis, in accordance with applicable law.