Life Sciences R&D Regulatory Affairs - Sr. Manager
The Team AI & 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 10/09/2024Work You'll Do About LSHC Throughout 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 Sciences Across 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 Senior Manager in our AI & Data team are expected to contribute to the firm's growth and development in a variety of ways, including:
Engagement Management: Lead engagement planning and budgeting; mobilize and manage engagement teams; define deliverable structure and content; facilitate buy-in of proposed solutions from top management levels at the client; direct on-time, quality delivery of work products; manage engagement economics; manage engagement risk
Client Management: Manage day to day interactions with executive clients and sponsors
Business Development: Develop and maintain contact with top decision makers at key clients; organize and lead pursuit teams; participate and lead aspects of the proposal development process; contribute to the development of proposal pricing strategies
People Development: Perform role of counselor and coach; provide input and guidance into the staffing process; actively participate in staff recruitment and retention activities; provide leadership and support for delivery teams and staff in local offices
Qualifications Required:
8+ years experience with relevant consulting experience.
4+ years of Life Sciences industry experience in the regulatory affairs function to include:
Regulatory operating model transformations
Regulatory digital transformations / innovations
Submissions management, labeling, CMC change control and/or LCM processes
Veeva RIM and/or QMS implementation
Understanding of regulatory data and regulatory filing requirements
Knowledge around generating submissions packages
AI/GenAI solutions for regulatory content or regulatory intelligence
3+ years experience leading, managing and delivering engagements end-to-end 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 available
Preferred:
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 organization
Information 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 $193,725 - $322,875.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&DE25 All 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.