- 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 ... for the Sr. Director, representing the Quality organization at senior levels. The Director plays a pivotal role in...regulatory requirements particularly in the areas of Medical Affairs and Clinical Development; Must have a strong understanding… 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...Medical strategy and execution.Primary Responsibilities:Leadership and ManagementServes as a senior leader in the USMA organization, sets the strategic… more
- 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)
- …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
- 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 ... unmet patient needs. We have more >150 US and International patents and market several branded ADHD products in...has an immediate opening for a Method Validation R&D Senior Scientist ISummary:The Method Validation (MV) Research and Development… 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
- 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
- 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...leveraging advanced project management practices in areas such as regulatory , quality, risk, procurement, and stakeholder engagement. 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...Medical Device Regulations, EU-MDR) + Problem solve and escalate regulatory and compliance issues to senior management… more
- Medtronic (Irvine, CA)
- …innovation in a more connected, compassionate world. **A Day in the Life** ** SENIOR REGULATORY AFFAIRS SPECIALIST - NEUROVASCULAR** _Onsite Position Located ... with US and EU regulatory requirements and partners with the international regulatory affairs group to support regulatory submissions. Sustaining … more
- BASF (Research Triangle Park, NC)
- **Now hiring! Senior Regulatory Affairs Manager** We are looking for a Senior Regulatory Affairs Manager to join our Agricultural Solutions team ... social value creation for sustainable andefficient agriculture. As a Senior Regulatory Affairs Manager, you... regulatory dossier submissions for US EPA and international regulatory authorities according to globally harmonized… more
- Danaher Corporation (Deer Park, IL)
- …Business Syste m (https://www.danaher.com/how-we-work/danaher-business-system) which makes everything possible. The Senior Principal, Regulatory Affairs is ... and digital pathology in the clinical oncology environment. The Senior Principal, Regulatory Affairs will...internal procedures are updated to reflect evolving US and international regulations. + Assess the impacts of relevant drug… more
- J&J Family of Companies (Cincinnati, OH)
- …Learn more at https://www.jnj.com/medtech We are searching for the best talent for a ** Senior Regulatory Affairs Program Lead** to support our Robotics & ... health for humanity. Learn more at https://www.jnj.com **Job Function:** Regulatory Affairs Group **Job Sub** **Function:** ...will help Robotics & Digital Solutions reach US and international regulatory (NPD) approval goals. Under minimal… more
- Ascendis Pharma (Princeton, NJ)
- …and committed to working together as one team to achieve extraordinary results. The Senior Manager Regulatory Affairs , Advertising and Promotion will be an ... the promotion of prescription drug and biologic products. The Senior Manager Regulatory Affairs , Advertising...to travel to various meetings including overnight trips. Some international travel may be required. + Requires up to… more
- Abbott (Santa Clara, CA)
- …medical device business units that Leveraged Services team supports. **The Opportunity** The ** Senior Manager Regulatory Affairs ** will work for our Global ... also have access to: + Career development with an international company where you can grow the career you...(FDA) Center for Devices and Radiological Health (CDRH). This Senior Manager Regulatory Affairs may… 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...development environment, including working within and managing across an international exposure. Leadership + Global perspective with a demonstrated… more
- Abbott (Santa Clara, CA)
- …catheters, imaging catheters and software, vessel closure devices and peripheral stents. This Senior Regulatory Affairs Specialist position is an onsite ... also have access to: + Career development with an international company where you can grow the career you...Division. As an individual contributor, the function of a Senior Regulatory Affairs Specialist is… more
- Stryker (Redmond, WA)
- We are currently seeking a ** Senior Regulatory Affairs Specialist** to join our **Medical** **Division** to be based **Hybrid** Monday through Wednesday in ... **Redmond, Washington.** **What you will do** As part of the Medical Regulatory Affairs team, you will work with the team to maintain medical devices on the… more
- BeOne Medicines (San Mateo, CA)
- …or health-related discipline, with at least 12+ years of experience in regulatory affairs , in advertising/promotion, labeling or related discipline + and ... medical affairs , and marketing. + Provide advice on healthcare regulatory matters across business functions, including commercial, clinical development, medical … more
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