- Lundbeck (Santa Monica, CA)
- …transform lives. Join us on our journey of growth! As a Psychiatry Account Manager , you lead the promotion of our psychiatry portfolio, executing sales and marketing ... issues (IDNs, Medicare, Medicaid, Commercial) using Lundbeck resources. Pharmaceutical Environment/ Compliance - Ability to apply knowledge of pharmaceutical and … more
- Lundbeck (Fort Collins, CO)
- …issues (IDNs, Medicare, Medicaid, Commercial) using Lundbeck resources. Pharmaceutical Environment/ Compliance - Apply knowledge of pharmaceutical and regulatory ... to stakeholders in the primary care and neurology settings. As an Account Manager , you lead the promotion of our psychiatry portfolio, executing sales and marketing… more
- Lundbeck (New York, NY)
- … regulatory environment, including Lundbeck policies and procedures and FDA regulations regarding the promotion of pharmaceutical and medical products. Ability ... the way in creating positive customer experiences! As a BioPharmaceuticals Account Manager , you lead the promotion of our infusion product, driving demand creation… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …center intake, Technical Complaints handling, customer care and Triage to ensure regulatory compliance Lead efforts to optimize call center workflows, implement ... internal workflow timelines and performance metrics to ensure departmental KPIs and regulatory compliance are met Lead deviation management activities, including… more
- Aequor (Athens, GA)
- …5 pm, no shift work Duties: Write analytical method validation protocol in compliance with all applicable FDA /EU/USDA regulations as well as corporate procedures ... validation test results in validation report Collaborate with the area manager (s) for project management, project timelines, regulatory documentation and… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …and develop talent. Ability to create an engaged workforce.GMP Compliance & Regulatory Knowledge: Deep understanding of FDA , EMA, and other global ... schedules.Will have 3-6 direct reports ranging from Associate Director, Senior Manager , and Manager .Oversee the hiring, development, and performance management… more
- Aequor (Tampa, FL)
- …instructions per Batch Record requirements for Packaging and Labeling processes in compliance with cGMP guidelines. This will require on time and neat documentation ... during the execution to assure compliance . Provide support to the Manufacturing Group, QA, Warehouse...Warehouse and Facility operations by complying with company and FDA cGMP requirements. Responsible for the performance of cleaning… more
- Repligen (Waltham, MA)
- …Notifications (SCNs)Evaluate and manage Supplier Change Notifications to ensure compliance with internal and regulatory quality standards.Coordinate ... You will a key role in ensuring the quality, compliance , and performance of Repligen's global supplier base. This...with eQMS systems or digital audit tools Familiarity with regulatory standards ( FDA , GMP, etc.). Excellent communication,… more
- Family Dollar (Chesapeake, VA)
- …a Food Safety and Quality Specialist and together be responsible for the Company's FDA regulatory compliance across FDA -regulated products, including ... only-No C2C-We do not provide sponsorship at this time ** FDA Reg Compliance Manager ** _About...develop innovative and effective solutions. + Act as the FDA Regulatory Compliance representative on… more
- Family Dollar (Chesapeake, VA)
- …Quality Assurance Manager for product quality, safety, efficacy, development, and compliance to cGMP requirements. You will be trained and qualified to perform ... industries. (pharmaceutical or medical device industry preferred). + Working knowledge of FDA Quality Systems (cGMP) and regulatory requirements (eg, 21 CFR… more
- Schwan's Company (Minneapolis, MN)
- …passionate about driving regulatory excellence across the supply chain? As our Sr Manager , FSQ Regulatory Compliance , you will play a critical role in ... providing expert guidance on regulatory requirements, product safety, labeling compliance (USDA/ FDA ), and special claims to support safe and compliant… more
- J&J Family of Companies (Danvers, MA)
- …in reviews of engineering, manufacturing, marketing, labeling and clinical documents for regulatory compliance . + Ability to effectively manage multiple projects ... We are searching for the best talent for a ** Manager , Regulatory Affairs** to support our Heart...and registries designed to support marketing applications. + Provide regulatory leadership of clinically focused FDA submissions… more
- Houston Methodist (Houston, TX)
- …**SERVICE ESSENTIAL FUNCTIONS** + Ensures compliance of general and study-specific regulatory and/or safety-related processes with SOP's, FDA , GCP, NIH and ... At Houston Methodist, the Regulatory Compliance Specialist position is responsible...International Conference on Harmonization (ICH). This position communicates with regulatory affairs office for FDA submissions across… more
- Houston Methodist (Houston, TX)
- …and safety reporting regulations, processes, and procedures under the direct supervision of the Regulatory Compliance Manager (serves as a resource for ... study specific processes under the direct supervision of the Regulatory Compliance Manager **QUALITY/SAFETY ESSENTIAL...+ Ensures compliance of general and study-specific regulatory and/or safety-related processes with SOP's, FDA ,… more
- Regeneron Pharmaceuticals (Sleepy Hollow, NY)
- …from the Regulatory Affairs, Advertising and Promotion Director. The Manager Regulatory Affairs, Advertising and Promotion will oversee therapeutic area(s) ... Manager , of Advertising and Promotion to join our Regulatory Affairs team!! **In this role, a typical day...matters, including request for advisory submissions. + Responsible for compliance with promotional material submissions to FDA … more
- 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...matters, including request for advisory submissions. + Responsible for compliance with promotional material submissions to FDA … more
- Unilever (El Segundo, CA)
- …partners. The Regulatory Affairs Manager will lead daily end-to-end regulatory support and systems to ensure continued compliance with established ... cross-functionally and provide regulatory expertise, to ensure compliance with applicable FDA , FTC, and state...LOCATION: El Segundo, CA HOURS: Full time, exempt (salaried) MANAGER : Sr. Director, Regulatory Affairs PLEASE NOTE:… 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 ... Regulatory team in preparing and filing 510(k), IDE, PMA submissions, FDA reports, all international regulatory submissions and registrations, responds to… more
- Dentsply Sirona (Milford, DE)
- …an internal champion for initiatives aimed at improving business systems and compliance . Key Responsibilities: + Develops and implements regulatory strategies to ... support to cross-functional teams throughout the product lifecycle. Reviews and interprets regulatory requirements and guidance documents to ensure compliance . +… more
- Haleon (Warren, NJ)
- …opportunity to be part of something special. **About the role** This **Senior Manager , Regulatory Affairs - OTC** has responsibility for end-to-end regulatory ... primarily internally facing. Because this role largely deals with regulatory strategy and compliance , impact can be...similar discipline + Minimum 8 years of experience in regulatory affairs + Experience working on FDA … more
