- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- … Regulatory Data Manager will be a key member of the Global Regulatory Affairs (GRA) Process Excellence function, responsible for driving data governance, ... people. Under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi...consistency and quality of data across key Daiichi Sankyo regulatory systems. This includes defining regulatory data… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …US regulatory activities. The Manager RPM is responsible for supporting the global regulatory lead (GRL), US regulatory lead (USRL) and global ... other research areas centered around rare diseases and immune disorders. Summary The Manager , Regulatory Affairs - Regulatory Project Management (RPM)… more
- Merck & Co. (North Wales, PA)
- … Regulatory Affairs Liaison, is responsible for development and implementation of global regulatory strategy for their assigned projects in the Vaccines and ... with the Worldwide Regulatory Agencies and/or subsidiaries with regard to global regulatory strategy/registration requirements for one or more of our… more
- 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
- Aequor (Thousand Oaks, CA)
- …license applications Serve as functional area lead on product teams (eg, Global Regulatory Team, Evidence Generation Team, Global Safety ... FULLY REMOTE Regulatory Writing Senior Manager ln this...Team, Label Working Group) Provide functional area input for Global Regulatory Plan and team goals Supervise… more
- Aequor (Thousand Oaks, CA)
- …and coordinate the preparation of regulatory submission documents that comply with global regulatory standards. Write or lead all aspects of the writing of ... FULLY REMOTE final BR - / hour Regulatory Writing Manager In this vital...All Studies, briefing documents, and safety narratives Write other regulatory submission documents (eg, RTQs, PIPs, white papers, breakthrough… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …relations, RD, global and US medical affairs and marketing, legal, regulatory and congress planning Qualifications: Successful candidates will be able to meet ... 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… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …GxP and Non-GxP activities, assuring that these systems are compliant with global regulatory and Daiichi Sankyo requirements, and business expectations. Executes ... a risk-based framework (Computer Software Assurance (CSA)) that is compliant with global regulatory expectations and business expectations to execute … 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 ... for supports of strategic leadership to manage DSI QA Functional activities and Global QA activities. This position performs support tasks Head Global R&D… more
- Catalent (San Diego, CA)
- Senior Manager , Quality AssurancePosition Summary:Catalent Pharma in San Diego, CA is hiring a Senior Manager of Quality Assurance (QA) at our Clinical Supplies ... a member of the Site Leadership Team, you will partner with the General Manager to create and sustain a site culture of Safety, Quality performance, Operational… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …a sound, overarching and competitive, asset strategy and execution to ultimately achieve global regulatory filings and ensure wide access of the compound. That ... 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… more
- Merck & Co. (Rahway, NJ)
- …to make decisions independently with limited oversight from Sr.COM or manager .Requires strong understanding of local regulatory environment.Ability to ... externally.Our Clinical Research and Pharmacovigilance team push the boundaries of global healthcare through research and innovation. Through clinical trials 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 ... strategy closely aligned with the business strategy within one or more Global Project Team(s) (GPT) within Oncology Development Franchises or Business Units. Provide… more
- Aequor (Thousand Oaks, CA)
- …level engagement. Job Title: Senior Project Manager - End to End Regulatory Content Automation Initiative, Global Regulatory Affairs and Strategy, ... of 5-8 YOE in project management within R&D and regulatory affairs, within pharmaceutical. Not a tech expert but...Position Summary: We are seeking a seasoned Project Manager with a proven track record in the pharmaceutical… 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
- Catalent (St. Petersburg, FL)
- QA Product ManagerPosition Summary The QA Product Manager provides customer service, with the highest integrity, focused on quality and compliance with partnership ... for their clients within the Catalent St. Petersburg site. The QA Product Manager is responsible for the overall Quality Assurance review and approval of all… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- Company Information Legend Biotech is a global biotechnology company dedicated to treating, and one day curing, life-threatening diseases. Headquartered in Somerset, ... and natural killer (NK) cell-based immunotherapy. Legend Biotech entered into a global collaboration agreement with Janssen, one of the pharmaceutical companies of… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …and clinical trials complaint handling Ensures local/affiliate SDEA templates meet both Global and local regulatory requirements Supports audit and inspection ... About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one...Support, NNI Legal, NNI Compliance, NNI Commercial, NNI Finance, Global Business Services (GBS), PV & GDP Auditor(s) as… more
- Merck & Co. (Durham, NC)
- Job DescriptionThe role of Operations Manager at our Company's Durham facility is a manufacturing leadership role. The individual in this role must provide ... of the team (eg documentation, housekeeping, area 5S, etc.)Participate in safety/ regulatory audits (ie tours, topic discussion)FinancialCoach the team to ensure SAP… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …for at least two global development projects that have been submitted to regulatory agencies preferred Travel Ability to travel up to 10% Daiichi Sankyo, Inc. is ... 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… more
