- Sumitomo Pharma (Concord, NH)
- …are currently seeking a dynamic, highly motivated, and experienced individual for the position of ** Director Regulatory Affairs ** . The Director is part ... of the Global Regulatory Affairs (GRA) team based in the US. He/she will...pharmaceutical industry with minimum of 8 years focused in regulatory affairs . + Master's degree required (preferably… more
- Sumitomo Pharma (Concord, NH)
- …seeking a dynamic, highly motivated, and experienced individual for the position of **Associate Director , Regulatory Affairs ** . The Associate Director ... is part of the Global Regulatory Affairs (GRA) team based in the US. He/she is...pharmaceutical industry with minimum of 6 years focused in Regulatory Affairs The base salary range for… more
- Merck (Concord, NH)
- …Drug-Device Combinations CMC (Chemistry, Manufacturing & Controls), you will report to the Director of Device Regulatory Affairs for Autoinjector Development ... control activities and documentation reviews + Provide evaluations of regulatory state of affairs of any devices and combination products, for due diligence… more
- Takeda Pharmaceuticals (Concord, NH)
- …of technical success for the solutions. + Effectively represent the Global Regulatory Affairs (GRA) function in senior level interactions at internally ... for providing strategic guidance and oversight for the delivery of global regulatory strategies to support development of biomarkers, diagnostic tests, devices and… more
- Sumitomo Pharma (Concord, NH)
- …website https://www.us.sumitomo-pharma.com or follow us on LinkedIn. **Job Overview** The Director , Medical Affairs Strategy (Hematology/Oncology) will be a key ... member of the Medical Affairs team reporting to the Executive Director ,...confidential. **Compliance** :Achieve and maintain Compliance with all applicable regulatory , legal and operational rules and procedures, by ensuring… more
- Sumitomo Pharma (Concord, NH)
- …Director , Medical Strategy (Rare Disease) will be a key member of the Medical Affairs team reporting to the Executive Director , Medical Affairs Strategy. ... company programs and external facing HCP and Payer interactions. The Sr. Director of Medical Affairs develops and maintains professional relationships with… more
- Sumitomo Pharma (Concord, NH)
- …, Medical Strategy (Women's Health) will be a key member of the Medical Affairs team reporting to the Executive Director , Medical Affairs Strategy. ... leadership and advance patient advocacy efforts to ensure that Medical Affairs activities align with patient focused programs. **Job Duties and Responsibilities**… more
- Merck (Concord, NH)
- **Job Description** **Role Summary** + The Health Systems Medical Affairs Director (HS MAD) is a therapeutic and disease expert who develops ongoing professional ... in a balanced and credible manner consistent with the regulatory environment and company's ethical standards. This role also...resource for the HS MAD Team Lead, HS Executive Director Medical Affairs , and other members of… more
- Sumitomo Pharma (Concord, NH)
- …. **Job Overview** Director , Field Medical and ... summarizes, and disseminates key insights obtained from the RDs to the Medical Affairs and other internal stakeholders in a timely manner. + Participate in the… more
- Tecomet (Woburn, MA)
- … Affairs Manager **Department:** Quality Assurance / Regulatory Affairs **Classification:** Exempt **Reports To:** Senior Director QARA **or EVP of ... provide overall company leadership and direction for Quality Assurance and Regulatory Affairs Systems, encompassing both improvements and sustaining activities… more
- Takeda Pharmaceuticals (Lexington, MA)
- …of proposed promotional and disease state materials. + Collaborate with Regulatory Affairs , Medical, Legal, Commercial, and Compliance, execute and ... to the best of my knowledge. **Job Description** **Associate Director , US Advertising & Promotion Regulatory Review**... regulatory requirements. + Understand broad concepts within Regulatory Affairs and potential effects across the… more
- Takeda Pharmaceuticals (Concord, NH)
- … Project Management and Strategic Planning - Neuroscience TAU within our Global Regulatory Affairs organization, based remotely. + Partners with the Global ... changes through proactive engagements with cross functional team members, Global Regulatory Affairs TAU colleagues and Global Regulatory Project Management… more
- United Therapeutics (Concord, NH)
- …primarily responsible for providing expert legal support to Marketing, Sales, Medical Affairs , Patient Relations, Regulatory Affairs and Corporate ... Company's various products. + Provide guidance to Sales, Marketing, Medical Affairs , Patient Relations, Regulatory and Corporate Compliance departments related… more
- Sumitomo Pharma (Concord, NH)
- …. **Job Overview** The **Executive Director Head of Medical Strategy** will ... be a key member of the Medical Affairs Leadership team reporting to the Vice President,...confidential. **Compliance** :Achieve and maintain Compliance with all applicable regulatory , legal and operational rules and procedures, by ensuring… more
- Novo Nordisk (Lexington, MA)
- …Clinical Operations, Non-Clinical Research, Medical Writing, Program Management, CMC and Regulatory Affairs teams. Will be interfacing with both internal ... to make a difference? The Position The International Medical Director serves as a subject matter expert for our...Operations, Non-Clinical Research, Medical Writing, Program Management, CMC and Regulatory Affairs teams to deliver and drive… more
- Novo Nordisk (Lexington, MA)
- …project teams, including Medical & Science, Clinical Operations, Biometrics, and Regulatory Affairs personnel, to manage preparation of the written ... and regulatory requirements of a clinical program. The Associate Director will provide high level strategic input into development plans, study designs,… more
- Takeda Pharmaceuticals (Lexington, MA)
- …potential issues. **POSITION ACCOUNTABILITIES:** + Collaborate with colleagues in Regulatory Affairs , Medical, Legal, Commercial, and Compliance organizations ... the US Medical team, you will report to the Director , Ad/Promo Regulatory Review. You will be... regulatory requirements. + Understand broad concepts within Regulatory Affairs and potential effects across the… more
- Novo Nordisk (Lexington, MA)
- …Nordisk US Clinical Development Group, whose functions include Drug Safety, Regulatory Affairs , Clinical Operations, Medical Writing, Biostatistics, Data ... excellent medical support to development programs at all stages + Provide support to Regulatory Affairs team members in the compilation of regulatory … more
- Takeda Pharmaceuticals (Concord, NH)
- …to bring life-changing therapies to patients worldwide. Join Takeda as Associate Director , Global Labeling Lead where you will be responsible for the development ... and assures that Takeda labeling content and processes conform to regulatory requirements. Management of Local Exceptions and LOC Interactions + Manages… more
- Globus Medical, Inc. (Methuen, MA)
- …CAPA, MDR, NCMR, and all relevant compliance activities + Work closely with Regulatory Affairs in planning, coordination, writing, and execution of 510(k), IDE ... Summary:** Our enabling technology division is searching for an enthusiastic Senior Director of Product Development to lead our navigation and computer vision team.… more