Senior Manager, Industry Solutions, Life Sciences, R&D

Industry Solutions, Life Sciences R&D Regulatory Affairs - Senior Manager

The Team

Deloitte’s Industry Solutions combine deep business experience with cutting-edge technologies to help solve your most pressing challenges. Designed for each sector and integrated with Deloitte’s unique IndustryAdvantage™ insights, our verticalized solutions are purpose-built for your needs. We help you transform the way you engage customers, deliver value, expand opportunities, and sustain the mission-critical operations at the heart of your business.

Work 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 health

As a Senior Manager you 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.

• 6+ 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 pharmaceutical submissions management, labeling, CMC change control and/or LCM processes
• Knowledge around generating pharmaceutical submissions packages
• Experience with Veeva RIM and/or QMS implementations

• 6+ 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:

• Demonstrated e