- 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...role will need to partner closely with teams and senior leaders from across Regulatory Affairs, as… more
- Aequor (Thousand Oaks, CA)
- FULLY REMOTE Regulatory Writing Senior Manager ln this vital role role you will serve as the functional area lead on product teams, lead writing activities ... license applications Serve as functional area lead on product teams (eg, Global Regulatory Team, Evidence Generation Team, Global Safety Team, Label Working… 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 ... compliance, and sound fiscal responsibility. The primary responsibilities of the Senior QA Manager include activities related to GMP (Good Manufacturing… more
- Aequor (Thousand Oaks, CA)
- …engagement. Job Title: Senior Project Manager - End to End Regulatory Content Automation Initiative, Global Regulatory Affairs and Strategy, Position ... of 5-8 YOE in project management within R&D and regulatory affairs, within pharmaceutical. Not a tech expert but...Summary: We are seeking a seasoned Project Manager with a proven track record in the pharmaceutical… more
- Merck & Co. (North Wales, PA)
- …in the Research & Development organization at our company. Position Description/Summary The Senior Specialist, Project Manager is a core member of Early Drug ... strategies and execute our Company's drug and vaccine development efforts. The Senior Specialist is expected to provide project management leadership and drive… more
- Aequor (Thousand Oaks, CA)
- The Supply Chain Project Manager (SCPM) will translate product variation strategy as determined by the Variation Lead for reportable changes for Global ... fully compliant (RFT) maintenance of Change Control Management system related to Global Distribution Change Records (GDCR) and/or Customer Facing SKU Change Records… 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 ... centered around rare diseases and immune disorders. Summary The Global Team Leader, is a senior , cross-functional...and leadership of clinical development plans, and addressing all regulatory , drug and patient safety, data, CMC, IP, patient… 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 ... of clinical studies, under the supervision of the Study Manager role the Study Associate Manager within...in evaluating study budgetsCollect information and coordinate with DS Regulatory Operations to post trial information on required public… 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
- Merck & Co. (Rahway, NJ)
- …the flow of data downstream for Analysis and Reporting. Interface with CDS manager /supervisor to assure consistency of technical and process strategies. Acts as a ... clinical database support to other departments. Assist clinical database manager /supervisor in project planning, manpower projections and resource allocations across… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Interaction & Collaboration level: Requires interaction with vendors and key senior stakeholders at Sr manager and director level in ... 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
- Aequor (Thousand Oaks, CA)
- …environment. The Capital Projects Sourcing Manager will report to the Category Senior Manager for Capital Construction and have the opportunity to work ... Understands contracting negotiations. is searching for a Capital Projects Sourcing Manager , who will be responsible for helping execute the sourcing processes… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- 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
- Novo Nordisk Inc. (Boulder, CO)
- …GMP manufacturing experience in the areas of biotechnology/pharmaceuticals. Relationships Senior Manager , Material Management. Essential Functions Manage ... analytical and process development, the CMC team works alongside Quality, Regulatory , Technical Operations and RNAi Early Development professionals at our Boulder,… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …communication and implementation of consistent processes across various product teams and global manufacturing sitesProvide updates to Senior Management on site ... and variances that occur during production or validationWork with Quality, Manufacturing, Regulatory , and subject matter experts to prepare for FDA and other agency… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …OR rep licensure), NNI government agreements (eg Corporate Integrity Agreement (CIA)) regulatory requirements (eg PDMA reporting) and the systems that support these ... Effectiveness, Clinical Operations and Marketing Effectiveness. Strong collaborations with senior leaders from Legal, Finance, Operations and Market Access as… more
- Merck & Co. (Millsboro, DE)
- …documentation, and other information as needed for annual reports to Federal regulatory agencies. Leadership for internal and external regulatory inspections ... team of animal care and testing specialists.Serve as a member of the Senior Leadership Team for the Millsboro, DE biologics manufacturing site.Lead numerous projects… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …and leadership for the investigations management system. Working closely with the Quality Senior Manager , this position will ensure alignment with all applicable ... Company Information Legend Biotech is a global biotechnology company dedicated to treating, and one day curing, life-threatening diseases. Headquartered in Somerset,… more
- AbbVie (Madison, NJ)
- …at www.abbvie.com. Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn. Job Description Senior Manager , Global Regulatory Strategy, US & ... with multiple driver indications within a Therapeutic Area and support the Manager , Global Regulatory Lead (GRL), Associate Director, or Director, in the… more
- Wells Fargo (Charlotte, NC)
- **About this role:** Wells Fargo is seeking a Engineering Senior Manager ( Global Regulatory Reporting) as part of the Wholesale Operations Technology ... This role will be accountable for the Wells Fargo Global Transaction Reporting ecosystem and will work closely with...Transaction Reporting ecosystem and will work closely with the Regulatory Reporting Product owner and team. This role will… more
