- Insmed Incorporated (Bridgewater, NJ)
- …Best Workplaces in New York™, and Best Workplaces for Millennials™ lists.OverviewThe Manager , Regulatory Operations will be responsible for functional activities ... Company DescriptionInsmed is a global biopharmaceutical company on a mission to transform...related to US/Ex-US regulatory submissions. In addition, this individual will be responsible… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …for cardiovascular diseases, under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily ... and the Oncology Business Unit globally; promote a quality culture within Global Medical Affairs Quality Assurance by providing study team support to uphold… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …opportunity employer including veterans and people with disabilities. Summary The Manager External Data Management, is accountable for an end-to-end delivery of ... data services they provide to support drug development processes and global submissions.This position provides expertise within Data Management by partnering with… more
- Novo Nordisk Inc. (Boulder, CO)
- … global requirements Develops comprehensive, relevant resources (eg training program , FAQs) to enable compliance to change control process requirements across ... analytical and process development, the CMC team works alongside Quality, Regulatory , Technical Operations and RNAi Early Development professionals at our Boulder,… more
- Eisai, Inc (NJ)
- …reviewing the clinical sections of submissions documents such as briefing books, Global Investigator Brochures (GIB) and annual regulatory reportsPrepare and ... is your profile, we want to hear from you. Job Summary The Senior Manager , Medical Writing will be the designated Lead Medical Writer for approximately 3-4 Programs.… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …for cardiovascular diseases, under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily ... responsible for creating and assisting in the development of compliance program trainings and communications, including developing eLearning modules. This position… more
- Novo Nordisk Inc. (Boulder, CO)
- … program teams. Physical Requirements Approximately 5% travel to Global Contract Manufacturing and Vendor Sites. Qualifications Education Level: PhD with ... analytical and process development, the CMC team works alongside Quality, Regulatory , Technical Operations and RNAi Early Development professionals at our Boulder,… more
- Insmed Incorporated (Bridgewater, NJ)
- Company DescriptionInsmed is a global biopharmaceutical company on a mission to transform the lives of patients living with serious and rare diseases. Our most ... Workplaces in New York™, and Best Workplaces for Millennials™ lists.OverviewThe Manager , Laboratory operations will manage the internal analytical laboratory and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …medicines to help people. Under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily ... as other research areas centered around rare diseases and immune disorders.Summary The Manager of Data Governance Stewardship will work in areas required for the… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- Position Summary:Oversee and lead the validation program for production equipment and processes used to support manufacturing of aseptic and terminally sterilized ... completionResponsible for drafting and providing technical guidance for the validation program , Policies and SOPs and other master documentsSupport Engineering and… more
- Kbr (Torrance, CA)
- …government services project within program guidelines established by the Program Manager , customer or contract stipulations.* Oversee/Manage a business ... agencies. KBRs areas of expertise include engineering, logistics, operations, science, program management, mission IT and cybersecurity.This role is with KBRs GAM,… more
- Eisai, Inc (Nutley, NJ)
- …to standards.Oversee regional security vendors.Prioritize risk-based reduction efforts. Manager investigations.General Compliance Activities:Maintain an inventory of ... play a pivotal role in ensuring the organization's adherence to security, regulatory , and compliance standards. Collaborating with business and EIT stakeholders, you… more
- Merck & Co. (Rahway, NJ)
- …product development planning to ensure that study designs are consistent with program objectives and meet worldwide regulatory needs.Independently identifies and ... analysis, and interpretation posed by scientists, Contract Research Organizations, and/or regulatory agencies.-May participate with manager in discussions with… more
- Novo Nordisk Inc. (Stamford, CT)
- About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the ... organization. From health-care-provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and collecting… more
- Merck & Co. (Millsboro, DE)
- …animal facilities as well as for the veterinary care and animal husbandry program at our company's Millsboro Animal Health facilities. This role is highly ... documentation, and other information as needed for annual reports to Federal regulatory agencies. Leadership for internal and external regulatory inspections… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Excellence Lead has a team reporting to them potentially inclusive of an operations & program manager , project managers, a business knowledge manager , and a ... governance across the portfolio to improve launch operations, business performance, program management, and knowledge management. This role is crucial in fostering… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …Nordisk's life-saving treatments are brought to life. Our manufacturing facility produces a global supply of our hemophilia and growth hormone product lines, as well ... (SOPs). Ensures quality control activities are aligned with industry, regulatory and corporate practice. Exercise judgment within generally defined practices… more
- Ingersoll Rand (Alsip, IL)
- …and critical applications. Are you ready to elevate your career with a global leader? Job SummaryEmbark on an exhilarating journey as our Manufacturing Technician, ... design of fixtures and material handling devices that comply with regulatory requirements to facilitate process efficiency.Support projects aimed at Safety, Quality,… more
- Regeneron Pharmaceuticals (Troy, NY)
- …with cross functional teams, contract manufacturing organizations, as well as global regulatory partners. + Participates in and leads cross-functional ... Regeneron is currently looking for a Manager for our CMC Regulatory Sciences...regulatory professional responsible for overseeing CMC aspects of global submissions, with a particular focus on rest of… more
- AbbVie (Madison, NJ)
- …Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn. Job Description Senior Manager , Global Regulatory Strategy, US & Canada, AbbVie Inc., ... driver indications within a Therapeutic Area and support the Manager , Global Regulatory Lead (GRL),...regulations, company policies, procedures, and guidance in alignment with regulatory product strategy and the Quality Dossier Program… more
Related Job Searches:
Global,
Global Manager,
Global Program,
Global Program Manager,
Manager,
Program,
Program Manager,
Regulatory,
Regulatory Manager,
Regulatory Program Manager