- Merck & Co. (San Diego, CA)
- …in Immunology.Experience with biologics or small moleculesSubstantial experience in US & International Regulatory Affairs with prior experience as a ... regional regulatory strategy and submissions through collaboration with Regulatory Affairs Europe (RAE) and local affiliate teams.Provide final… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Executive Director (ED) for US Medical Affairs (USMA) understands Our Company's enterprise level strategies and leads cross-functionally with the ... Global Medical and Scientific Affairs Therapeutic Area (GMSA TA) teams to translate Global Value and implementation (V&I) goals into the relevant US country-level… more
- Insmed Incorporated (San Diego, CA)
- …for Women™, Best Workplaces for Millennials™, and Best Medium Workplaces™ lists.OverviewThe Director, Regulatory Affairs will serve as the regulatory leader ... (fast track, RMAT, etc.)Proactively communicate issues, outcomes, and risks to the VP of Regulatory Affairs and relevant teamsWith oversight from the VP of … more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …in quality and compliance.Evaluate risks impacting GxP compliance within Medical Affairs , driving ongoing improvements to meet regulatory requirements and ... authority regulatory requirements particularly in the areas of Medical Affairs and Clinical Development; Must have a strong understanding of pharmaceutical drug… more
- Merck & Co. (Rahway, NJ)
- …studies.Work closely with a cross-functional group of experts in commercialization, regulatory affairs , statistics, and manufacturing to manage clinical ... Neuropathic Pain, Neuroscience, Neuroscience Research, Pain Management, Pharmaceutical Development, Regulatory Affairs Compliance, Regulatory Compliance,… more
- Eisai, Inc (Nutley, NJ)
- …of relevant medical communications deliverables aligned with the Medical Affairs strategic plan for assigned therapeutic area(s). These deliverables include ... interactions with KOLs (ie by MSLs), advisory boards, internal medical affairs strategic communication tools (ie medical narratives) and other internal medical… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …(eg SOPs) as appropriate.Collaborate with cross-functional teams (eg, Medical Safety, Regulatory Affairs , Epidemiology) to ensure benefit-risk integration to ... processes across the global safety organization. The incumbent will ensure regulatory compliance, promote best practices, foster a culture of continuous improvement… more
- Genmab (NJ)
- … regulatory policy and/or intelligence deliverables. This role will be within Global Regulatory Affairs (GRA) and will report to the Sr. Director, Labeling, ... a fit? Then we would love to have you join us!The Global Regulatory Labeling, Policy and Intelligence Associate Director will primarily be responsible for leading… more
- Eisai, Inc (Nutley, NJ)
- …the health economics and outcomes research strategies, and timelines with medical affairs , marketing, managed markets and global value and access teams. Projects ... to Eisai's products and appropriate medical care.Travel to national and international meetings and conferences to support the business needs. Requirements Doctoral… more
- Tris Pharma (Monmouth Junction, NJ)
- …in liaison with Product Development (PD)/Quality Assurance (QA)/Quality Control (QC)/ Regulatory Affairs , including reviews/approvals of Change Control Reports ... pain and addiction addressing unmet patient needs. We have more >150 US and International patents and market several branded ADHD products in the US We also license… more
- Tris Pharma (Monmouth Junction, NJ)
- …advocate for data-driven decision-making across departments (eg, Commercial, Medical Affairs , Regulatory , Manufacturing, Finance)Manages a small, high-performing ... anxiety, pain and addiction addressing unmet patient needs. We have >150 US and International patents and market several branded ADHD products in the US We also… more
- AbbVie (Mettawa, IL)
- …LinkedIn and Tik Tok (https://www.tiktok.com/@abbvie) . Job Description The Director, International Regulatory Affairs Advertising & Promotion safeguards ... global regulatory strategy and global brand plan and leads the international regulatory strategy for the assigned marketed and development compounds.The… more
- Bath & Body Works (New York, NY)
- …our communities and our planet to help the world live more fully.Overview The International Regulatory Affairs Manager position will be responsible for ... compliance strategy for global market. This role, reporting to Principal, International Regulatory Affairs (Associate Vice President) is responsible for… more
- Stryker (Flower Mound, TX)
- **Senior Project Manager, International Regulatory Affairs ** _San Jose, CA / Flower Mound, TX / Kalamazoo, MI_ Stryker is hiring a Senior Project Manager, ... International Regulatory Affairs , to expand global access to our Endoscopy division product portfolio within APAC. In this strategic leadership role, you will… more
- BD (Becton, Dickinson and Company) (San Diego, CA)
- **Job Description Summary** As Staff Regulatory Affairs Specialist, you will be responsible for supporting MMS Dispensing products consisting of Medical Devices ... Software and Accessories on a global basis from a Regulatory Affairs standpoint. Support will consist of...Support the monitoring and interpreting of current and new regulatory requirements and international standards for US… more
- Hologic (Louisville, CO)
- Regulatory Affairs Specialist, International Marlborough, MA, United States Louisville, CO, United States **Join Our Team: Regulatory Affairs ... make a real impact in healthcare innovation? As a Regulatory Affairs Specialist supporting our dynamic Surgical...materials, and user manuals for compliance with US and international regulatory requirements. + Identify and recommend… more
- Medtronic (Santa Rosa, CA)
- …cross functional members at varying levels within the organization as well as International Regulatory Affairs staff. Strategic direction is expected to ... together to engineer the extraordinary. Join a diverse team of Regulatory Affairs Professionals who bring their knowledge, their unique backgrounds, and their… more
- Medtronic (Irvine, CA)
- …for compliance with US and EU regulatory requirements and partners with the international regulatory affairs group to support regulatory submissions. ... in a more connected, compassionate world. **A Day in the Life** **SENIOR REGULATORY AFFAIRS SPECIALIST - NEUROVASCULAR** _Onsite Position Located at Our UCI… more
- BD (Becton, Dickinson and Company) (Franklin Lakes, NJ)
- … strategies to partners. + Assist and manage Notification of Change (NOC)/ International Regulatory Affairs assessments of PLM/Sustaining activities to ... your expertise and grow in your career. Our Staff Regulatory Affairs Specialist position is primarily focused...new 510(k) submissions, CE marking applications, and support our international regulatory team in further launch activities.… more
- Merck (Austin, TX)
- …+ Experience with biologics or small molecules + Substantial experience in US & International Regulatory Affairs with prior experience as a Global ... + Coordinate regional regulatory strategy and submissions through collaboration with Regulatory Affairs Europe (RAE) and local affiliate teams. + Provide… more
