Pharma R&D Regulatory Affairs Manager - Deloitte
Cincinnati, OH 45201
About the Job
Position Summary
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 12/16/2024.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 intelligenceUnderstanding of pharmaceutical regulatory data and regulatory filing requirementsExperience with pharmaceutical regulatory operating model transformationsExperience with regulatory digital transformations / innovationsExperience with submissions management, labeling, CMC change control and/or LCM processesKnowledge around generating pharmaceutical submissions packagesExperience with Veeva RIM and/or QMS implementations1+ years experience leading, managing and delivering complex engagements with resources in multiple locationsBachelor’s DegreeAbility to travel up to 50% on average, based on the work you do and the clients and industries/sectors you serveLimited immigration sponsorship may be availablePreferred:Ability to orchestrate, lead, and influence virtual teams, ensuring successful implementation of customer projectsPresentation skills with a high degree of comfort with both large and small audiencesDemonstrated 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 discussionsStrong problem solving and troubleshooting skills with the ability to exercise mature judgmentDemonstrated experience with management and delivery of multiple strategic engagements for large global organizationInformation 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 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&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: 202373AccoladesData Analytics
| Data EngineeringSame job available in 33 locations
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 12/16/2024.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 intelligenceUnderstanding of pharmaceutical regulatory data and regulatory filing requirementsExperience with pharmaceutical regulatory operating model transformationsExperience with regulatory digital transformations / innovationsExperience with submissions management, labeling, CMC change control and/or LCM processesKnowledge around generating pharmaceutical submissions packagesExperience with Veeva RIM and/or QMS implementations1+ years experience leading, managing and delivering complex engagements with resources in multiple locationsBachelor’s DegreeAbility to travel up to 50% on average, based on the work you do and the clients and industries/sectors you serveLimited immigration sponsorship may be availablePreferred:Ability to orchestrate, lead, and influence virtual teams, ensuring successful implementation of customer projectsPresentation skills with a high degree of comfort with both large and small audiencesDemonstrated 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 discussionsStrong problem solving and troubleshooting skills with the ability to exercise mature judgmentDemonstrated experience with management and delivery of multiple strategic engagements for large global organizationInformation 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 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&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: 202373AccoladesData Analytics
| Data EngineeringSame job available in 33 locations
Source : Deloitte