- Takeda Pharmaceuticals (Boston, MA)
- …in order to bring life-changing therapies to patients worldwide. Join Takeda as Senior Manager , Global Regulatory Labeling Strategy where you will be ... and/or related experience. + Knowledge of US and EU product labeling regulatory requirements and guidelines. + Familiarity with US and/or EU regulatory… more
- Parexel (Des Moines, IA)
- …in a matrix organization. * Strong knowledge of US, EU, DE, CH, AU regulatory labeling lifecycle management. * Experience with flu campaigns, pandemic products, ... Join us as a **Global Labeling Operations Manager ** , where you'll...years of biotech/pharma industry experience, including 2+ years in labeling / regulatory operations with global responsibility. * Experience… more
- Boehringer Ingelheim (Ridgefield, CT)
- … for NCEs/NBEs and labeling supplements, in conjunction with the assigned RA Labeling Content Manager and Product Manager in the RA Product Groups. ... labeling initiatives in compliance with Corporate and local regulatory requirements. The AD, DRA Product Labeling ...to be able to properly understand the implications of labeling decisions throughout the business Manager : +… more
- Taiho Oncology (Princeton, NJ)
- …environment. + Minimum 7 years' experience in pharmacovigilance, drug safety, or regulatory labeling within the pharmaceutical or biotechnology industry. + ... a transformative journey with Taiho Oncology as a Senior Manager , Global Labeling and PV Operations. At...and others) are current, accurate, and compliant with global regulatory requirements for ICSR assessments. The position also supports… more
- Danaher Corporation (Miami, FL)
- …Intern will gain hands-on experience and exposure in the critical area of regulatory labeling within the medical device and Life Sciences industry. Interns ... projects to meet FDA, EU, IVDR, ISO, CLP/GHS, and other countries' regulatory requirements. . Support the management of labeling change control processes,… more
- Grifols Shared Services North America, Inc (Clayton, NC)
- …required for registration and routine product shipments. + Evaluate impact of new labeling regulatory requirements as well as evaluate changes to existing ... , labeling requirements, and implementation. Coordinate and submit all regulatory documentation for establishment of new / changed local market authorization… 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 ... global development projects and provide regulatory strategy for assigned projects that leads to a...project team meets US requirements in development activities. The manager will be responsible for FDA meetings and submissions… 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 ... NJ; Spring House, PA; or San Diego, CA. The Manager , Regulatory Scientist is a regulatory...to understand the competitive landscape, eg, views of HAs, regulatory precedents, labeling differences and therapeutic area… 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 ... and line extensions. + Assists in review of product labeling and marketing materials. + Provides regulatory ...product labeling and marketing materials. + Provides regulatory oversight of changes in manufacturing facilities, processes, and… more
- Schwan's Company (Minneapolis, MN)
- …about driving regulatory excellence across the supply chain? As our Sr Manager , FSQ Regulatory Compliance, you will play a critical role in ensuring ... and Preventive Controls Qualified Individual (PCQI), providing expert guidance on regulatory requirements, product safety, labeling compliance (USDA/FDA), and… more