Life Sciences R&D Regulatory Affairs – Manager at Deloitte
Cincinnati, OH 45201
About the Job
Position Summary
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 10/23/2024Work 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 health As 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. Qualifications Required: 6+ 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 intelligence1+ years experience leading, managing and delivering complex technology engagements with resources in multiple locationsBachelor’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:The 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 - $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&DE25
Recruiting tips
From developing a stand out resume to putting your best foot forward in the interview, we want you to feel prepared and confident as you explore opportunities at Deloitte. Check out recruiting tips from Deloitte recruiters.
Benefits
At Deloitte, we know that great people make a great organization. We value our people and offer employees a broad range of benefits. Learn more about what working at Deloitte can mean for you.
Our people and culture
Our diverse, equitable, and inclusive culture empowers our people to be who they are, contribute their unique perspectives, and make a difference individually and collectively. It enables us to leverage different ideas and perspectives, and bring more creativity and innovation to help solve our client most complex challenges. This makes Deloitte one of the most rewarding places to work. Learn more about our inclusive culture.
Our purpose
Deloitte’s purpose is to make an impact that matters for our clients, our people, and in our communities. We are creating trust and confidence in a more equitable society. At Deloitte, purpose is synonymous with how we work every day. It defines who we are. We are focusing our collective efforts to advance sustainability, equity, and trust that come to life through our core commitments. Learn more about Deloitte's purpose, commitments, and impact.
Professional development
From entry-level employees to senior leaders, we believe there’s always room to learn. We offer opportunities to build new skills, take on leadership opportunities and connect and grow through mentorship. From on-the-job learning experiences to formal development programs, our professionals have a variety of opportunities to continue to grow throughout their career.
As used in this posting, "Deloitte" means Deloitte Consulting LLP, a subsidiary of Deloitte LLP. Please see for a detailed description of the legal structure of Deloitte LLP and its subsidiaries.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.Deloitte will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles’ Fair Chance Initiative for Hiring Ordinance. See notices of various ban-the-box laws where available.Requisition code: 197398AccoladesData Analytics
| Data EngineeringSame job available in 33 locations
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 10/23/2024Work 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 health As 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. Qualifications Required: 6+ 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 intelligence1+ years experience leading, managing and delivering complex technology engagements with resources in multiple locationsBachelor’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:The 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 - $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&DE25
Recruiting tips
From developing a stand out resume to putting your best foot forward in the interview, we want you to feel prepared and confident as you explore opportunities at Deloitte. Check out recruiting tips from Deloitte recruiters.
Benefits
At Deloitte, we know that great people make a great organization. We value our people and offer employees a broad range of benefits. Learn more about what working at Deloitte can mean for you.
Our people and culture
Our diverse, equitable, and inclusive culture empowers our people to be who they are, contribute their unique perspectives, and make a difference individually and collectively. It enables us to leverage different ideas and perspectives, and bring more creativity and innovation to help solve our client most complex challenges. This makes Deloitte one of the most rewarding places to work. Learn more about our inclusive culture.
Our purpose
Deloitte’s purpose is to make an impact that matters for our clients, our people, and in our communities. We are creating trust and confidence in a more equitable society. At Deloitte, purpose is synonymous with how we work every day. It defines who we are. We are focusing our collective efforts to advance sustainability, equity, and trust that come to life through our core commitments. Learn more about Deloitte's purpose, commitments, and impact.
Professional development
From entry-level employees to senior leaders, we believe there’s always room to learn. We offer opportunities to build new skills, take on leadership opportunities and connect and grow through mentorship. From on-the-job learning experiences to formal development programs, our professionals have a variety of opportunities to continue to grow throughout their career.
As used in this posting, "Deloitte" means Deloitte Consulting LLP, a subsidiary of Deloitte LLP. Please see for a detailed description of the legal structure of Deloitte LLP and its subsidiaries.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.Deloitte will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles’ Fair Chance Initiative for Hiring Ordinance. See notices of various ban-the-box laws where available.Requisition code: 197398AccoladesData Analytics
| Data EngineeringSame job available in 33 locations
