- Takeda Pharmaceuticals (Boston, MA)
- …in order to bring life-changing therapies to patients worldwide. Join Takeda as Associate Director , Global Labeling Lead where you will be responsible for ... approval by Labeling Senior Management Cross-functional team ( Global Labeling Oversight Committee - GLOC) driving...+ Liaises with US Labeling Operations, EU Labeling Operations, Labeling Devices Lead… more
- Takeda Pharmaceuticals (Boston, MA)
- …possible in order to bring life-changing therapies to patients worldwide. Join Takeda as Director , Global Regulatory Labeling Strategy where you will be ... approval by Labeling Senior Management Cross-functional team ( Global Labeling Oversight Committee - GLOC) providing...+ Liaises with US Labeling Operations, EU Labeling Operations, Labeling Devices Lead… more
- Wolters Kluwer (Chicago, IL)
- …regulations, 510(k)s, labeling and promotional materials, 21 CFR 820, global medical device registration, technical writing, and external standards. ... locations on the posting). **OVERVIEW** You will be the global product quality lead in support of a broad...in support of a broad portfolio of on-market medical devices including Software as a Medical Device … more
- Lundbeck (Deerfield, IL)
- …+ Demonstrated team leadership and motivation of staff to successfully execute global labeling regulatory strategies. + Knowledge of development and registration ... Director US Regulatory Global Strategic Labelling...development, regulatory submission and launch. + Supports Lundbeck Product Labeling Committee activities, coordinating and collaborating with Global… more
- AbbVie (North Chicago, IL)
- …lead several internal and external artwork development and proofreading teams across AbbVie's global commercial product labeling and US promotional labeling . ... . Job Description Management of functional and strategic leadership of AbbVie's global artwork development business and core leader in the Global … more
- Lilly (Indianapolis, IN)
- … Global Regulatory Team consisting of regional regulatory scientists, GRA-CMC, GRA- Devices , GRA-RD&E, and GRA- Global Labeling and Product Communications. ... a global regulatory strategy which supports product (including delivery device and relevant medical devices ) development, registration, and lifecycle… more
- Sanofi Group (Cambridge, MA)
- **Job Title:** Associate Director , Global Regulatory Affairs Advertising and Promotion **Location** : Cambridge, MA Morristown, NJ **About the Job** Are you ... of Prescription Drug Promotion (OPDP) and Advertising and Promotion Labeling Branch (APLB). We are an innovative global...and updating of standards and processes related to drug, device , and biologics US AdPromo regulations and guidances. +… more
- Caldera Medical (Westlake Village, CA)
- …the Quality of Life for Women! Message from the Hiring Manager: The Director of Regulatory Affairs will lead global regulatory strategy, manage submissions, ... Director of Regulatory Affairs ONSITE in Westlake Village,...of progressive experience in regulatory affairs within the medical device industry. * Proven track record with global… more
- Lundbeck (Deerfield, IL)
- …advocacy, medical publications, and trial engagement materials. + Provide directions to global labeling processes, including inform decisions on Target Product ... Director Regulatory Affairs Alliance and Commercialization - Remote...and expertise of regulations across scientific messaging, promotional compliance, global regulatory strategic labeling and regulatory strategy.… more
- Edwards Lifesciences (Irvine, CA)
- …while minimizing potential legal risks. This role requires deep knowledge of global medical device -industry, including the regulatory landscape, authorities and ... adherence to various laws and regulations around the globe specific to medical device companies (eg, labeling regulations, anti-kickback laws, false claims laws,… more
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