- 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
- Aequor (Newbury Park, CA)
- …and develop solutions. Provide Subject Matter Expertise in Veeva Vault Configuration and Regulatory Processes to a global user base. Develop and deliver training ... This will be a 100% remote role. The hiring manager confirmed they are looking for someone who works...materials and presentations to a global audience. Author/review/approve quality Regulatory Information Management… 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 (NJ)
- …/ Strong knowledge of the global drug development process and global regulatory requirements. Proficient and strong analytical skills. Strong communication ... 100 % remote Manager prefers local candidates (will consider non local...Management and Monitoring (GSMM), Project Management, Client Affiliates, Medical Affairs (MA), Regulatory , CMC, QA, Packaging Vendors,… 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
- 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 ... Visits Reports and escalates performance issues and training needs to CRA manager and/or functional vendor and internal management as needed. Performs Quality… 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
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …but not limited investor relations, RD, global and US medical affairs and marketing, legal, regulatory and congress planning Qualifications: Successful ... 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)
- …CRD as needed.-Works in partnership with GCTO country operations, finance, regulatory affairs ,-pharmacovigilance, legal and regional operations, HQ functional ... Job DescriptionWith support of Sr CRA/CRA and/or CRA Manager , acts as primary site contact and site manager -throughout all phases of a clinical research study,… 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 (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
- Bausch Health (Bothell, WA)
- …care options to consumers and physicians alike. Reporting to the Sr. Director, Global Regulatory Affairs , the Senior Manager , Regulatory Affairs ... for their globally distributed products. This role is not a regional regulatory but global regulatory position which under the organization of Solta Medical… more
- AbbVie (Lake Bluff, IL)
- …Twitter, Facebook, Instagram, YouTube and LinkedIn. Job Description The Associate Director, Regulatory Affairs , Strategic Global Labeling - Combination ... Global industry trends and best practices in combination product and device regulatory affairs , review and comment on changing regulation and guidance. +… 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
- 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
- Stryker (Portage, MI)
- …quality products and solutions in a timely manner. We are currently seeking a ** Manager , Regulatory Affairs , State Licensing** to join our **Corporate** ... based in **Portage, Michigan.** **What you will do** **The Manager , Regulatory Affairs , State Licensing,...stakeholders. + Interact with groups within the organization, including global regulatory team, governmental affairs ,… more
- BD (Becton, Dickinson and Company) (San Diego, CA)
- **Job Description Summary** As Manager , Regulatory Affairs , you will provide leadership to the MMS -Pharmacy Automation platform team. You will contribute to ... pre-market regulatory leadership to MMS-PA business + Directs premarket regulatory affairs activities which may include interactions between MMS-PA and… 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
- ICU Medical (Lake Forest, IL)
- …and will not be discriminated against on the basis of disability. **Title:** * Regulatory Affairs Manager * **Location:** *IL-Lake Forest* **Requisition ID:** ... Job Title Manager , Regulatory Affairs -...Job Title Manager , Regulatory Affairs - Electromechanical Devices FLSA...Manager who assists in development and execution of Global Regulatory Strategies and Plans to assure… more
