About the Role

　　Onsite, hybrid

　　#LI-Hybrid #LI-Onsite

　　Bringing life-changing medicines to millions of people, Novartis sits at the intersection of cutting-edge medical science and innovative digital technology. Navigate helps turn innovative treatment ideas into reality and has directly contributed to the approval of more than 10 therapies to address unmet medical needs for patients.

　　In this role, you will be a part of the Business Operations team within Navigate and will be primarily responsible for providing strategic product direction as well as directing and coordinating the submission of regulatory documents for regulated IVD products in development. This role will actively participate on project teams, identifying gaps or risks, with the goal of ensuring regulatory compliance to ensure timely approval of new medical devices and continued approved status of marketed medical devices.

　　Your key responsibilities:

　　• Actively creates, approves and submits regulatory documents including IDEs, PMAs and PSAs, performance study application and IRB submissions, briefing books, periodic experience reports, progress reports, amendments, supplements, summary documents and correspondence.

　　• Drives coordination and planning of all activities associated with submissions, including preparation of regulatory documents to ensure timely completion and submission of dossiers with adherence to timelines worldwide. Develops and implements plans to avoid/minimize clock stops during submission review.

　　• Provides strategic product direction to teams on interaction and negotiates evidence with regulatory agencies. Includes providing advice to development and/or marketing teams on manufacturing changes, technical labeling, appropriate regulations and interpretations.

　　• Interacts and negotiates with regulatory agency personnel to expedite approval of pending registration and answers any questions. Develops and implements plans for timely response to health authority requests and coordinates responses.

　　• Primary contact and manages responsibility of global regulatory consultants, charged with communications, regulatory filings, timing, etc. to ensure compliance with relevant health authorities.

　　• Provides input into and implements regulatory strategy and manages operational activities for assigned projects globally

　　• Review and submit Risk Management Plans. Identifies gaps and or risks and supports development of mitigation strategies.

　　• Implements policies, procedures and best practices for regulatory affairs, collaborates with cross-functional teams within business units to develop and execute regulatory strategies from product inception to product launch. Serves as a regulatory liaison on the project team throughout the product lifecycle.

　　• Provides project management services as needed to support regulatory/GXP projects.

　　• Demonstrates good judgment in selecting methods and techniques for obtaining solutions.

　　Diversity & Inclusion / EEO

　　We are Equal Opportunity Employers and take pride in maintaining a diverse environment. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status. We are committed to building diverse teams, representative of the patients and communities we serve, and we strive to create an inclusive workplace that cultivates bold innovation through collaboration and empowers our people to unleash their full potential.

　　Accessibility and Reasonable Accommodations: Individuals in need of a reasonable accommodation due to a medical condition or disability for any part of the application process, or to perform the essential functions of a position, please let us know the nature of your request, your contact information and the job requisition number in your message:

　　Novartis: e-mail [email protected] or call +1 (877)395-2339Sandoz: e-mail [email protected] or call: +1-609-422-4098

　　Role Requirements

　　• BS or MS in a scientific discipline, with 5+ years of direct regulatory experience with a 3+ years experience in IVD

　　• Ability to write high quality submission documentation

　　• Ability to handle multiple tasks and to prioritize and schedule work to meet business needs

　　• Ability to identify areas of concern in moderately complex projects and lead changes

　　• Excellent communication, organization and time management skills

　　• Functional breadth of knowledge and ability to apply sound judgment and discretion

　　• Strong business mindset, interpersonal skills, critical thinking skills and resilience

　　Desired:

　　• Project management and/or IVD assay development experience preferred

　　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? https://www.novartis.com/about/strategy/people-and-culture

　　Benefits and Rewards: Read our handbook to learn about all the ways we'll help you thrive personally and professionally: https://www.novartis.com/careers/benefits-rewards

　　Commitment to Diversity & Inclusion: The Novartis Group of Companies are Equal Opportunity Employers and take pride in maintaining a diverse environment. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status. We are committed to building diverse teams, representative of the patients and communities we serve, and we strive to create an inclusive workplace that cultivates bold innovation through collaboration and empowers our people to unleash their full potential.

　　Novartis Compensation and Benefit Summary: The pay range for this position at commencement of employment is expected to be between $118,400 - $177,600/year; however, while salary ranges are effective from 1/1/23 through 12/31/23, 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.

　　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: https://talentnetwork.novartis.com/network

　　Division

　　Operations

　　Business Unit

　　CONTRACT MANUFACTURING

　　Location

　　USA

　　Site

　　Carlsbad, CA

　　Company / Legal Entity

　　Navigate BioPharma Svcs., Inc.

　　Functional Area

　　Research & Development

　　Job Type

　　Full Time

　　Employment Type

　　Regular

　　Shift Work

　　No