- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …as other research areas centered around rare diseases and immune disorders. Summary The Manager , Regulatory Affairs - Regulatory Project Management (RPM) ... and coordination supports for global and US regulatory activities. The Manager RPM is responsible... Manager RPM is responsible for supporting the global regulatory lead (GRL), US regulatory… more
- Aequor (Newbury Park, CA)
- … processes and deliverables. Works under under the direction of a Global or US Regulatory Lead or Manager and will assist in the creation and submission of ... zone based on business needs in the evenings. Ideal Candidate: Previous Regulatory Experience professionally is highly preferred. Knowledge of FDA. Degree in life… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …The Regulatory Data Manager will be a key member of the Global Regulatory Affairs (GRA) Process Excellence function, responsible for driving data ... role will need to partner closely with teams and senior leaders from across Regulatory Affairs , as well as cross-functional stakeholders (eg, RA CMC, R&D… more
- Aequor (Thousand Oaks, CA)
- …license applications Serve as functional area lead on product teams (eg, Global Regulatory Team, Evidence Generation Team, Global Safety ... Team, Label Working Group) Provide functional area input for Global Regulatory Plan and team goals Supervise the work of contract and freelance writers and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …specialty and the Oncology Business Unit globally; promote a quality culture within Global Medical Affairs Quality Assurance by providing study team support to ... with stakeholders and QA line functions. Support the annual Quality Plan for Global Medical Affairs Quality Assurance, PVQA strategic plans and the tracking… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …efficiencies. Key internal stakeholder relationships include Scientific Communications, NNI Medical Affairs , Global Medical Affairs , Health Economics ... About the Department The Clinical Development, Medical and Regulatory (CMR) department at Novo Nordisk is one...ready to make a difference? The Position The Project Manager , Accelerated Efficiencies and Optimization, will drive execution of… more
- Merck & Co. (Rahway, NJ)
- …with HQ functions, regional and local operations, EU Clinical-Development, Pharmacovigilence, Global Medical Affairs to align on key issues/decisions-across the ... and adverse event reporting-requirements internally and externally.The CRM (Clinical Research Manager ) could be responsible for a particular study for several… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and will work regularly with all business areas (Sales, Marketing, Clinical, TMPC, Med Affairs , and Regulatory Affairs ) and support functions (IT, Finance, ... for cardiovascular diseases, under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily… more
- Lundbeck (Chicago, IL)
- …include continuous collaboration with all relevant support departments: marketing, medical affairs , regulatory , IT, sales operations, commercial analytics, etc., ... be their best. Inspired and driven by our purpose, we are the only global biopharmaceutical company focused solely on brain diseases. We have a robust and innovative… more
- Merck & Co. (North Wales, PA)
- …and Translational Medicine, Global Medical and Scientific Affairs , and Global Regulatory Affairs and Clinical Safety to identify key issues ... Scientist is expected to collaborate with our company's colleagues from Global Clinical Development, Biostatistics and Research Decision Sciences, the Center for… more
- Aequor (Thousand Oaks, CA)
- …? Serve as the primary interface with Clinical Development, Quality, Biostatistics, Regulatory Affairs , Corporate Planning, and Operations to ensure coordination ... Remote role - need to work Pacific zone hours Manager would prefer candidates who are local to sit...resourcing, and budget projections ? Determine distribution strategies for global studies. ? Articulate clinical supply chain management processes… more
- Takeda Pharmaceuticals (Boston, MA)
- …best of my knowledge. **Job Description** Takeda Development Center Americas, Inc. is seeking a Manager , Global Regulatory Affairs CMC in Cambridge, MA ... with the following requirements: Master's degree in Regulatory Affairs or related field plus 2...working in close coordination with the quality, manufacturing and global regulatory teams; Ensure the response to… more
- Takeda Pharmaceuticals (Boston, MA)
- …of my knowledge. **Job Description** Takeda Development Center Americas, Inc. is seeking a Manager , Global Regulatory Affairs , Marketed Products in ... EU, Health Canada, and other international health authorities - Support regulatory team and Global Regulatory Lead (GRL) in preparations and timely delivery… more
- Takeda Pharmaceuticals (Lexington, MA)
- …of my knowledge. **Job Description** Takeda Development Center Americas, Inc. is seeking a Manager , Global Regulatory Affairs CMC Submissions Management ... requirements and priorities; develop/maintain strong working relationships with the regulatory CMC team and cross-functional teams, participate on and/or lead… more
- ICON Clinical Research (Farmingdale, NY)
- …helping shape an industry. As Regulatory Manager , you will work in Global Regulatory Affairs team, a successful and driven team that provides ... teams and have regulatory project management experience. The role: As a Regulatory Affairs Manager you will need to be experienced with In Vitro… more
- STERIS (St. Paul, MN)
- …documents. Utilizes electronic record-keeping tools according to departmental policy. The Senior Regulatory Affairs Manager is expected to have in-depth ... Senior Manager , International Regulatory Affairs ...lines in support of registration requirements. + Develop sound global regulatory strategies for new products. Identify… more
- ADM (Quincy, IL)
- **83436BR** **Job Title:** Regulatory & Scientific Affairs Manager - Quincy, IL **Department/Function:** Legal, Compliance, Regulatory Affairs , ... Corporate Security **Job Description:** ** Regulatory & Scientific Affairs Manager - This position may be...Quincy, IL; Harvard, IL** **Your Responsibilities** Reporting to the Global Head Regulatory Affairs this… more
- AbbVie (Irvine, CA)
- ….allerganaesthetics.com/. Follow Allergan Aesthetics on LinkedIn. Job Description Description The Manager Regulatory Affairs represents US regulatory ... affairs for device development projects. Executes US regulatory strategic plans and provides guidance to Global... regulatory strategic plans and provides guidance to Global Regulatory Lead (GRL) and project team.… more
- Teleflex (Morrisville, NC)
- Sr. Regulatory Affairs Manager - Product Management **Date:** Jun 4, 2024 **Location:** Morrisville, NC, US **Company:** Teleflex **Expected Travel** : Up to ... a difference in patients' lives. **Position Summary** The Senior Manager , Regulatory Affairs is an...an experienced leadership position with a deep understanding of global regulatory requirements, a strong track record… more
- The US Pharmacopeial Convention (USP) (Rockville, MD)
- …Job Overview** The Senior Manager , Public Policy in International Government and Regulatory Affairs (IGRA) is an integral position within a global ... the policy content generated and managed by the Senior Manager will be utilized in dialogues with policy makers...execution of key projects within the International Government & Regulatory Affairs Team and broader Global… more
