- THE MARKET (St. Thomas County, VI)
- …adherence to all applicable health and safety regulations including Food Safety and regulatory duties required in the department. Pay has room for growth depending ... veal, poultry). . Prepares specialty meat merchandise . Checks product to make sure it meets quality standards. ....motions: bending, twisting, squatting and reaching. . Exposure to FDA approved cleaning chemicals. . Exposure to temperatures: <32… more
- 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
- 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 (Milford, DE)
- …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
- Dentsply Sirona (Sarasota, FL)
- …**Job Summary:** **The Senior Manager of Regulatory Affairs supports regulatory affairs activities for US FDA 510k submissions, Health Canada medical ... guidance and support to cross-functional teams throughout the product lifecycle + Reviews and interprets regulatory ...Experience with leading regulatory submissions and managing regulatory projects + In-depth knowledge of FDA … 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
- Takeda Pharmaceuticals (Boston, MA)
- …medicines and make a lasting impact on patients worldwide. Join Takeda as a Senior Manager , Global Regulatory Lead Oncology where you will be part of the global ... ensure the global regulatory strategy is updated and executed, ensuring global regulatory compliance. + May communicate with FDA as required. + Ensure… more
- ThermoFisher Scientific (Frederick, MD)
- …is safe or helping find cures for cancer. **Discover Impactful Work** As a Sr. Manager , Regulatory Affairs, you will play a crucial role in interpreting and ... and communicate the impact of relevant global regulations, guidelines, and evolving regulatory trends relating to pharmaceutical product development in the area… more
- Reckitt (Evansville, IN)
- Regulatory Manager City: Evansville **We are Reckitt** Home to the world's best loved and trusted hygiene, health, and nutrition brands. Our purpose defines why ... in our great organisation. **About the role** This pivotal Regulatory Manager role offers you the opportunity...focus on infant,children, and adult categoriesin order to provide regulatory guidance and expertise throughout the whole product… more
- Boehringer Ingelheim (Ridgefield, CT)
- …Ingelheim, in conjunction with RA Product Labeling Management and the assigned RA Product Manager in the RA Product Groups. * Demonstrate proficient and ... Fellowship is designed to provide pharmacists with exposure to regulatory requirements for US package and product ...and prepare regulatory labeling documents needed for regulatory labeling submissions. * Assist with FDA … more
- Bausch Health (Bothell, WA)
- …well as leadership and guidance on global regulatory strategy, such as US FDA product clearance, Health Canada registration, CE Marking, global product ... itwhere your skills and values drive our collective progress and impact. The Manager , Regulatory Affairs will be responsible for: + Responsible for developing… more
- Abbott (Alameda, CA)
- …working mothers, female executives, and scientists. + The Opportunity - We are seeking a Regulatory Affairs Project Manager to join our Lingo team in Alameda CA. ... As an individual contributor, the function of a Regulatory Affairs Project Manager is to combine... risks of division policies, processes, procedures + Provide regulatory input to product lifecycle planning +… more
- Chiesi (Boston, MA)
- …for the better. Who we are looking for Purpose Responsible for the regulatory review and submission of advertising and promotional materials for multiple Chiesi ... to existing labeling, and submission of labeling information to regulatory authorities in the United States and Canada. Main...and by attendance of major FDLI, DIA and other industry/ FDA meetings. + Ensures that changes in US Prescribing… more
- BD (Becton, Dickinson and Company) (Warwick, RI)
- …and support the proposed product claims. + Review CMC changes and determine regulatory reporting category in accordance with FDA guidance for changes to an ... not limited to healthcare antiseptic products. Under the mentorship of the Sr. RA Manager of Regulatory Affairs, they are responsible for the development of… more
- Nestle (Chicago, IL)
- …and promotion. They will ensure regulatory compliance, provide strategic regulatory guidance, and support product launches and commercialization throughout ... harnessing their collective strength to empower healthier lives. Our broad product portfolio includes renowned brands like Garden of Life(R), Nature's Bounty(R),… 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
- 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
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