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

  • The Team

  • DescriptionDirector, Life Sciences Alvarez & Marsal (A& M) is a premier independent global professional services firm specializing in providing turnaround management, restructuring, performance improvement, and corporate advisory services.At A& M, our Life Sciences practice provides a broad range of services for our clients who are operating in an industry with high risks and rewards. We understand the urgency of their business and put our expertise to work when they need it most - when there are no second chances, company futures are on the line, and past attempts must now succeed. When time is of the essence, our clients turn to us - trusting we have the experience and solutions to help them reach their goals. Goals like successfully navigating financial constraints, maximizing a key product launch to ensure that patients can access the medicines they need, or effectively scaling during periods of rapid growth. Come be part of a team that is making an impact on the lives of so many. Join us in making a difference.Our team prides itself on sustaining a culture that reflects our core values. We value integrity, quality, and objectivity in our work. We believe every day is a choice, and so we like what we do and with whom we do it. We embrace diversity, foster inclusiveness, and reward merit. We encourage and support our employees and communities through ongoing investments from leadership, social and networking events, peer-to-peer networks, Employee Resource Groups, volunteer opportunities, and pro-bono work. We are committed to promoting an inclusive environment in which all can develop, grow, and be supported. What will you be doing? As a Director, you will be leading a team and acting as the main conduit between our clients and our team on a range of complex assignments. You will manage projects by overseeing interview activities, gathering relevant data, developing goals and deadlines, reviewing work products of junior staff, and communicating with clients directly.The duties of a Director may vary depending on the client engagement but can include:

  • Description

  • Specialty/Competency: Technology Strategy

  • Are you customer focused, enjoy building relationships and providing financial solutions to your clients? You have found the right team.

  • Company Description

  • Company Description

Job Details

Jocancy Online Job Portal by jobSearchi.