- Regeneron Pharmaceuticals (Sleepy Hollow, NY)
- … regulatory landscape. + Counseling on all aspects of product commercialization, including launch preparation, launch execution, market development, disease ... law. Possess a solid understanding of the biotech/pharmaceutical industry, including product development, commercialization, and the legal and regulatory … more
- Wolters Kluwer (Waltham, MA)
- ** Regulatory Initiatives Product Manager ** Wolters Kluwer is a global leader in professional information and software solutions, trusted by clinicians and ... bold thinking and collaboration shape the future of healthcare. This is a product management role focused on integrating regulatory and compliance considerations… more
- Schwan's Company (Minneapolis, MN)
- …Qualified Individual (PCQI), providing expert guidance on regulatory requirements, product safety, labeling compliance (USDA/ FDA ), and special claims to ... excellence across the supply chain? As our Sr Manager , FSQ Regulatory Compliance, you will play...regulatory expert, and manage complex compliance programs including product safety, labeling, import/export, and crisis management. If you… 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
- Globus Medical, Inc. (Audubon, PA)
- …can resume their lives as quickly as possible. **Position Summary** **:** The Manager , Regulatory Affairs, is responsible for preparing, filing and gaining ... team in preparing and filing 510(k), IDE, PMA submissions, FDA reports, all international regulatory submissions and...systems and line extensions. + Assists in review of product labeling and marketing materials. + Provides regulatory… more
- Dentsply Sirona (Waltham, MA)
- …for mentoring and providing guidance to their direct reports and cross-functional product development teams on US and EU regulatory requirements. This ... regulatory guidance and support to cross-functional teams throughout the product lifecycle. Reviews and interprets regulatory requirements and guidance… more
- AbbVie (North Chicago, IL)
- …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 and Canada is responsible… more
- CSL Behring (King Of Prussia, PA)
- …to actively contribute to an innovative, scientifically sound, global, integrated regulatory vision/strategies for assigned product /s with a patient-centric ... insights and applying prudent risk-taking to ensure timely delivery of successful regulatory outcomes. Effectively partner with assigned product /s Global … more
- Otsuka America Pharmaceutical Inc. (Augusta, ME)
- …drug products and drug-device combination products. Ensure compliance with global regulations ( FDA , EMA, ICH, WHO) and anticipate regulatory changes impacting ... strategies for post-approval changes, line extensions, and global harmonization of product registrations. Monitor and implement regulatory updates impacting… more
- Stryker (Mahwah, NJ)
- **Senior Manager , Regulatory Affairs - Joint Replacement Division** **Location:** Hybrid - Mahwah, NJ As the **Senior Manager , Regulatory Affairs** , you ... global regulatory strategies, submission preparation and approvals for new product launches and patient-specific solutions. You will work across the … more
- Grifols Shared Services North America, Inc (Clayton, NC)
- …in more than 110 countries and regions. **Summary:** Implement worldwide regulatory product registration strategies, prepare complex registration dossiers, ... combination of education and experience. + Extensive knowledge of applicable worldwide regulatory product registrations laws and regulations. + Excellent verbal… more
- J&J Family of Companies (Titusville, NJ)
- …Johnson & Johnson Innovative Medicine R&D is recruiting for a Manager , Regulatory Scientist. This position is a hybrid role ... in Titusville, NJ; Raritan, NJ; Spring House, PA; or San Diego, CA. The Manager , Regulatory Scientist is a regulatory specialist with project management… more
- BD (Becton, Dickinson and Company) (Franklin Lakes, NJ)
- …a **maker of possible** with us. **Job Overview** Working closely with the Director of Regulatory Affairs, the Regulatory Affairs Manager - RA Strategy Lead ... will provide proactive regulatory surveillance. They will develop regulatory strategies for product creation and market entry. They will also serve as the … more
- Regeneron Pharmaceuticals (Tarrytown, NY)
- The Senior Manager , Regulatory Affairs will report to the Global Regulatory Liaison (GRL) and provides support to the GRL in all aspects of regulatory ... + Coordinate the preparation, submission, management and maintenance of global regulatory submissions related to clinical and nonclinical aspects of product… more
- Boehringer Ingelheim (Ridgefield, CT)
- …labeling for NCEs/NBEs and labeling supplements, in conjunction with the assigned RA Labeling Content Manager and Product Manager in the RA Product ... of process to support labeling initiatives in compliance with Corporate and local regulatory requirements. The AD, DRA Product Labeling Operations will provide… more
- BD (Becton, Dickinson and Company) (Durham, NC)
- …standards. The role may also be responsible for assessing changes to commercialized product to determine the worldwide regulatory impact of the change, preparing ... Summary** This position will be working in BD-Connected Care on Regulatory Affairs projects that support the Pharmacy Automation business. This role… more
- Oracle (Little Rock, AR)
- …our next-generation EHR and AI-enabled medical device platforms. As a Clinical Product Manager (Medical Device Focus), you'll provide clinical insight into ... for Clinical Evaluation Reports (CERs), including alignment with EU MDR and FDA regulatory requirements. . Oversee usability engineering (IEC 62366), ensuring… more
- Oracle (Helena, MT)
- …our next-generation EHR and AI-enabled medical device platforms. As a Clinical Product Manager (Medical Device Focus), you'll provide clinical insight into ... for Clinical Evaluation Reports (CERs), including alignment with EU MDR and FDA regulatory requirements. . Oversee usability engineering (IEC 62366), ensuring… more
- Medtronic (Minneapolis, MN)
- … regulatory issues and questions from regulatory agencies. + Prepare FDA , European, and Canadian submissions for product changes to ensure timely approval ... the Americas and the EU. **Role Overview** The Senior Regulatory Affairs Specialist develops strategies for worldwide product...for market release. + Review significant regulatory issues with the manager as necessary,… more
- Bristol Myers Squibb (Princeton, NJ)
- … FDA regulations and guidances. **Responsibilities include:** + Provides regulatory advice, risk assessment and mitigation strategies to Commercial Teams, Medical ... development of promotional campaigns and materials for an assigned product /therapeutic area in order to help ensure the Company's...compliance of all promotions with approved labeling and /or FDA guidances + Ensure regulatory compliance with… more