The Regulatory Diagnostics Manager (RDM) for Precision Diagnostics is responsible for implementation of strategic plans for development of diagnostics, including companion diagnostics (CDx), as they pertain to the Novartis innovative medicines portfolio, including its marketed products. The RDM works with oversight of senior members of the Regulatory Affairs Precision Diagnostics Team including the TA and Diagnostics Lead on strategies and submissions including companion diagnostics, in close collaboration with internal RA Disease Unit associates, associates of Digital, Data and Clinical Innovation (DDCI) at Novartis as well as Partner Companies that develop diagnostics and ensures adherence to regulatory requirements. The RDM will also provide regulatory support including tactical and technical regulatory direction for clinical trial assays to ensure compliance with regulations on diagnostics.
Key Responsibilities:
Regulatory Strategy and Implementation
Training and Compliance
Performance Indicators
Essential Requirements:
Senior Manager:
The pay range for this position at commencement of employment is expected to be between $114,100 and $211,900 (Manager) & $145,600 and $270,400 (Sr. Manager)/year; however, while salary ranges are effective from 1/1/25 through 12/31/2025, fluctuations in the job market may necessitate adjustments to pay ranges during this period. Further, final pay determinations will depend on various factors, including, but not limited to geographical location, experience level, knowledge, skills and abilities. The total compensation package for this position may also include other elements, including a sign-on bonus, restricted stock units, and discretionary awards in addition to a full range of medical, financial, and/or other benefits (including 401(k) eligibility and various paid time off benefits, such as vacation, sick time, and parental leave), dependent on the position offered. Details of participation in these benefit plans will be provided if an employee receives an offer of employment. If hired, employee will be in an “at-will position” and the Company reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors.
Why Novartis : Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together?
Benefits and Rewards : Read our handbook to learn about all the ways we’ll help you thrive personally and professionally:
Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together?
Join our Novartis Network: Not the right Novartis role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up:
Benefits and Rewards: Read our handbook to learn about all the ways we’ll help you thrive personally and professionally:
EEO Statement:
The Novartis Group of Companies are Equal Opportunity Employers. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, sex, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status.
Accessibility & Reasonable Accommodations
The Novartis Group of Companies are committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or to perform the essential functions of a position, please send an e-mail to [email protected] or call +1(877)395-2339 and let us know the nature of your request and your contact information. Please include the job requisition number in your message.
What's This All About?Perfect Search offers a Remote Digital Marketing Internship program focused on learning pay-per-click advertising/search engine marketing (PPC/SEM), display/programmatic advertising, and social media advertising, as well as search engine optimization...
...VDC & BIM Manager Work Location: 601 First Street NW, Grand Rapids, MI 49504 Position Classification: Full Time Exempt About This Opportunity Rockford is looking for a key member of Virtual Design Construction team. Leading BIM Coordination process and assisting...
...is a leading Portuguese manufacturer of high-quality MDF Carb P2 panels, free of solvents... ...and Tampa areas and seeking a skilled sales representative to drive growth in this key... ...areas as needed. Compensation: ~100% commission-based with competitive commission rates....
...opportunity is closed, they will hand off management of the relationship to our Corporate... ...overall policy framework. Strong customer service skills (friendly, courteous and helpful)... ..., Veritiv is the leading full-service provider of packaging solutions. Veritiv also provides...
...Overview WeWork Reforma Latino (97001), Mexico, Ciudad de Mexico, Ciudad de Mexico Software Engineer - Full Stack Do you love building and pioneering in the technology space? Do you enjoy solving complex business problems in a fast-paced, collaborative, inclusive...