- Hologic (Marlborough, MA)
- Regulatory Affairs Specialist, Medical Device Louisville, CO, United States Marlborough, MA, United States **Join Hologic's Surgical Division as a ... industry. **What You'll Bring:** **Experience** + 2-5 years in regulatory affairs , preferably within the medical...Understanding of ISO 13485, ISO 9001, FDA, and international regulatory requirements. + Data and statistical analysis… more
- J&J Family of Companies (Raynham, MA)
- …and profoundly impact health for humanity. Learn more at https://www.jnj.com **Job Function:** Regulatory Affairs Group **Job Sub** **Function:** Regulatory ... We are searching for the best talent for a ** Regulatory Affairs Specialist II** to support our...of claims, content labeling, and promotional materials. + Defines data and information needed for regulatory approvals.… more
- Takeda Pharmaceuticals (Boston, MA)
- …with immunologic, hematologic, and other complex diseases. The Head of Global Regulatory Affairs Operations, Compliance & Process Excellence is accountable for ... overseeing Global Regulatory Affairs Operations across the entire PDT...Excellent communicator, able to persuasively convey both ideas and data , verbally and in writing. + Proven skills as… more
- Sanofi Group (Cambridge, MA)
- …Director collaborates closely with cross-functional teams, including Global Regulatory Affairs , Clinical Development, Safety, and Medical Affairs , to ... **Job Title:** Associate Director, Global Regulatory Affairs - Global Labeling Strategy...assigned products throughout their lifecycle. + Collaborate with clinical, medical , safety, and regulatory colleagues to provide… more
- Sumitomo Pharma (Boston, MA)
- …highly motivated, and experienced individual for the position of Vice President, Regulatory Affairs , Biopharma R&D. This position leads the Regulatory ... CNS assets. **Job Duties and Responsibilities** **_Regulatory Strategy_** + Develop and Manage Regulatory Affairs Strategy + Develop and gain approval for … more
- Fresenius Medical Center (Waltham, MA)
- …regulatory strategy and market access plans. + Utilize market intelligence and regulatory data to optimize product lifecycle management, regulatory ... (Advanced degree such as a Master's, PhD, or MBA is highly preferred). + Regulatory Affairs Certification (eg, RAC) is preferred. + **Experience:** + 12+ years… more
- Hologic (Marlborough, MA)
- …and foreign (EU, Canada, etc.) regulatory requirements. + Understanding of data /statistical analysis. + Regulatory Affairs Certification (RAC) and ... degree in a technical field preferred. + 2-5 years' experience in regulatory affairs ( medical device industry). + Experience with technical documentation and… more
- Sanofi Group (Cambridge, MA)
- …+ Provide regulatory labeling leadership to cross-functional teams ( Regulatory Strategy, Clinical Development, Medical Affairs , Pharmacovigilance, ... **Job Title:** Director, Global Regulatory Affairs - Global Labeling Strategy...+ Scientific rigor and analytical ability to interpret complex data and develop regulatory -sound labeling content. +… more
- Takeda Pharmaceuticals (Boston, MA)
- …bring life-changing therapies to patients worldwide. The Associate Director Global Regulatory Affairs , Neuroscience is responsible for developing innovative ... appropriate regulatory strategy. + Participates in cross-functionalinitiativeswithin Global Regulatory Affairs and Takeda R&D. **How you will contribute:**… more
- Takeda Pharmaceuticals (Boston, MA)
- …to bring life-changing therapies to patients worldwide. The Associate Director, Global Regulatory Affairs Advertising and Promotion (GRA A&P) Review Lead is ... you will contribute:** + As our Associate Director, Global Regulatory Affairs Advertising and Promotion lead you...Advisor and function as the "R" in the core Medical , Legal, and Regulatory review functions within… more