Global Regulatory Affairs Manager

this role, you will be a part of the Regulatory 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 device clinical studies, continued approval of investigational IVD studies, through filing and approval of new medical devices (IVDs). Your Key Responsibilities:

Actively creates, approves and submits regulatory documents including significant risk determination (SRDs), Investigational Device Exemption (IDEs), and Performance Study Applications (PSA), Annex XIV documentation and Institutional Review Board (IRB) submissions, briefing books, progress reports, amendments, supplements, substantial modifications, summary documents and correspondence directly or through legal representativeDrives 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 reviewProvides strategic product direction to teams on interaction and negotiates evidence with regulatory agencies.

Includes providing advice to development teams on manufacturing changes, impact assessments, technical labeling, appropriate regulations and interpretations. Provides input into and implements regulatory strategy and manages operational activities for assigned projects globallyInteracts 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 responsesPrimary contact for and manages relationship with global regulatory consultants and legal representatives, charged with communications, regulatory filings, timing, etc. to ensure compliance with relevant health authorities.

Maintain and leverage data and metrics for efficient management of regulatory activities within and across projectsImplements 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. Demonstrates good judgment in selecting methods and techniques for obtaining solutions.

Erroneous decisions result in critical delays and modifications to projects or operations; cause substantial expenditure of additional time, human resources, and funds; and jeopardize future business activityProvides project management services as needed to support regulatory/GXP projectsEssential Requirements:

BS or MS in a scientific discipline, with 5+ years or direct regulatory experience with 3+ years experience in IVDAbility to write high quality submission documentationAbility to handle multiple tasks and to prioritize and schedule work to meet business needsAbility to identify areas of concern in moderately complex projects and lead changesExcellent communication, organization and time management skillsFunctional breadth of knowledge and ability to apply sound judgment and discretionStrong business mindset, interpersonal skills, critical thinking skills and resilienceDesired Requirements:

Project Management and/or IVD assay development experienceClinical and/or compliance experienceThe salary for this position is expected to range between $114,100 and $211,900 per year. The final salary offered is determined based on factors like, but not limited to, relevant skills and experience, and upon joining Novartis will be reviewed periodically. Novartis may change the published salary range based on company and market factors. Your compensation will include a performance-based cash incentive and, depending on the level of the role, eligibility to be considered for annual equity awards.

US-based eligible employees will receive a comprehensive benefits package that includes health, life and disability benefits, a 401(k) with company contribution and match, and a variety of other benefits. In addition, employees are eligible for a generous time off package including vacation, personal days, holidays and other leaves.