- Regeneron Pharmaceuticals (Sleepy Hollow, NY)
- …the Regulatory Affairs, Advertising and Promotion Director. The Senior Manager Regulatory Affairs, Advertising and Promotion will oversee therapeutic area(s) ... The Senior Manager position within the Regulatory Affairs...Form 2253 + Monitor the external environment to advise product teams on evolving regulatory requirements related… more
- Boehringer Ingelheim (St. Joseph, MO)
- **Description** Manager The Manager , Regulatory Affairs (RA) Pharma Safety & Efficacy will represent the US regulatory safety and efficacy function in ... project team meets US requirements in development activities. The manager will be responsible for FDA meetings...accordance with the project governance model to drive Target Product Profile objectives. + Provides consistent regulatory … more
- Ascendis Pharma (Princeton, NJ)
- …to working together as one team to achieve extraordinary results. The Senior Manager Regulatory Affairs, Advertising and Promotion will be an internal expert ... promotion of prescription drug and biologic products. The Senior Manager Regulatory Affairs, Advertising and Promotion is...product (s) and will ensure materials are submitted to FDA via 2253. + Support metrics to measure and… more
- Abbott (Santa Clara, CA)
- …to support clinical trial activities and product launches. The Senior Manager leads project submissions for regulatory approvals and acts independently to ... CA currently has an on-site opportunity for a **Senior Regulatory Affairs Manager - Transcatheter** **Mitral Valve...regulatory submission experience, with substantial knowledge of US FDA Medical Device Regulatory Requirements for class… more
- Abbott (Alameda, CA)
- …their glucose levels with our new sensing technology. **The Opportunity** This ** Regulatory Affairs Manager - International Compliance Operations** will work ... their glucose levels with our new sensing technology. This ** Regulatory Affairs Manager - International Compliance Operations**...+ Assist in SOP development and review + Provide regulatory input to product lifecycle planning +… more
- Abbott (Sylmar, CA)
- …Our location in **SYLMAR, CA** currently has an onsite opportunity for a Manager of Regulatory Affairs in the Cardiac Rhythm Management Business. This ... regulatory strategies, submissions to support clinical trial activities and product launches. This individual applies advanced regulatory expertise to guide… more
- AbbVie (San Francisco, CA)
- …compliance with regulations, company policies, procedures, and guidance in alignment with regulatory product strategy and the Quality Dossier Program (QDP). This ... YouTube, LinkedIn and Tik Tok (https://www.tiktok.com/@abbvie) . Job Description The Senior Manager , RA Global Regulatory Strategy, US & Canada position is… more
- Sumitomo Pharma (Lincoln, NE)
- …a dynamic, highly motivated, and experienced individual for the position of Senior Manager , Regulatory Operations, For assigned projects, the Senior Manager ... Manages the planning, tracking, compiling, quality checking and submission of required FDA Submissions (eg Establishment Registrations, Drug Product Listings). +… more
- Amneal Pharmaceuticals (Piscataway, NJ)
- …overseeing regulatory activities related to Field Alert Reports (FARs), product recalls, and market withdrawals, including investigation management, FDA ... Description: The Manager , Field Alert & Recall Compliance is responsible...Functions: + Will be the contact person for the FDA and other regulatory agencies in regard… more
- FREEMAN (New York, NY)
- …The ideal candidate will have a strong background in engineering, safety, and regulatory compliance. You will lead the product management structures team and ... + Testing and Validation: Develop and execute testing plans to validate product performance, safety, and regulatory compliance. + Documentation: Maintain… more
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