This listing was posted on ListedBuy.
Senior/Global Regulatory Manager
Location:
Abee
Description:
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. Visit ListedBuy for more information.
Company:
Novartis
Posted:
January 6 on ListedBuy
Visit Our Partner Website
This listing was posted on another website. Click here to open: Go to ListedBuy
Important Safety Tips
- Always meet the employer in person.
- Avoid sharing sensitive personal and financial information.
- Avoid employment offers that require a deposit or investment.
To learn more, visit the Safety Center or click here to report this listing.
More About this Listing: Senior/Global Regulatory Manager
Senior/Global Regulatory Manager is a Executive Manager Job at Novartis located in United States. Find other listings like Senior/Global Regulatory Manager by searching Oodle for Executive Manager Jobs.
Senior/Global Regulatory Manager is a Executive Manager Job at Novartis located in United States. Find other listings like Senior/Global Regulatory Manager by searching Oodle for Executive Manager Jobs.