Life Sciences R&D Regulatory Affairs - Sr. Manager

Life Sciences R&D Regulatory Affairs - Sr. Manager

02 Oct 2024
New York, New york city 00000 New york city USA

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.

Related jobs

  • Specialty/Competency: Technology Strategy

  • We are the leading provider of professional services to the middle market globally, our purpose is to instill confidence in a world of change, empowering our clients and people to realize their full potential. Our exceptional people are the key to our unrivaled, inclusive culture and talent experience and our ability to be compelling to our clients. You\'ll find an environment that inspires and empowers you to thrive both personally and professionally. There\'s no one like you and that\'s why there\'s nowhere like RSM.

  • Qualifications:

  • OverviewBaker Tilly is a leading advisory, tax and assurance firm, providing clients with a genuine coast-to-coast and global advantage in major regions of the U.S. and in many of the world\'s leading financial centers - New York, London, San Francisco, Los Angeles, Chicago and Boston. Baker Tilly Advisory Group, LP and Baker Tilly US, LLP (Baker Tilly) provide professional services through an alternative practice structure in accordance with the AICPA Code of Professional Conduct and applicable laws, regulations and professional standards. Baker Tilly US, LLP is a licensed independent CPA firm that provides attest services to its clients. Baker Tilly Advisory Group, LP and its subsidiary entities provide tax and business advisory services to their clients. Baker Tilly Advisory Group, LP and its subsidiary entities are not licensed CPA firms.Baker Tilly Advisory Group, LP and Baker Tilly US, LLP, trading as Baker Tilly, are independent members of Baker Tilly International, a worldwide network of independent accounting and business advisory firms in 141 territories, with 43,000 professionals and a combined worldwide revenue of $5.2 billion. Visit bakertilly.com or join the conversation on LinkedIn, Facebook and Instagram. Please discuss the work location status with your Baker Tilly talent acquisition professional to understand the requirements for an opportunity you are exploring.Baker Tilly is an equal opportunity/affirmative action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability or protected veteran status, gender identity, sexual orientation, or any other legally protected basis, in accordance with applicable federal, state or local law.Any unsolicited resumes submitted through our website or to Baker Tilly Advisory Group, LP, employee e-mail accounts are considered property of Baker Tilly Advisory Group, LP, and are not subject to payment of agency fees. In order to be an authorized recruitment agency (\"search firm\") for Baker Tilly Advisory Group, LP, there must be a formal written agreement in place and the agency must be invited, by Baker Tilly\'s Talent Attraction team, to submit candidates for review via our applicant tracking system.Job Description: ResponsibilitiesDue to the continued growth of our Consulting practice, we are currently recruiting for a Senior Consultant to join our Baker Tilly Healthcare Consulting Practice. As a part of Baker Tilly Consulting, you will find that our global brand and entrepreneurial environment will give you the support you need to apply your industry and technical experience to build your career across a wide range of services to meet our client\'s most important needs. As a member of our team, you will also contribute to some of the most important activities in our firm which include operating and growing the business, serving the client, developing the best people, and shaping our culture.The senior consultant position will be actively involved in a variety of projects, with a focus on the life sciences industry, within Baker Tilly\'s consulting arm. The selected candidate will use their industry knowledge and technical, analytical and research skills in support of our clients\' project needs in the practice areas of life science, provider, and health plan. Responsibilities will include:

  • Serves as a risk officer for the Client organization’s Exam Management and Regulatory Liaison Office responsible for the promotion, support, monitoring and reporting on Citi’s interactions with its regulators, including queries arising in the normal course of business outside of specific examinations, and managing supervisory examinations, globally.

  • Business Title: Manager, Corporate Affairs

  • Regulatory Project Manager

Job Details

Jocancy Online Job Portal by jobSearchi.