- System One (Malvern, PA)
- Job Title: Director of Regulatory and Medical Affairs Location: Malvern, PA Type: Direct Hire Essential Duties/Responsibilities: + Manage Regulatory ... in life sciences related field. + RAC certification. + 15+ years Regulatory Affairs in medical device field with management responsibilities. + Strong… more
- Teva Pharmaceuticals (West Chester, PA)
- Director , Regulatory Affairs - Dossier Project Manager Date: Jun 20, 2025 Location: West Chester, United States, Pennsylvania, 19380 Company: Teva ... Medicine Dossier Project Manager, a key member of Global Regulatory Affairs , will be responsible to develop...regulatory project plans for major global dossiers. The Director that fills this highly visible role will work… more
- Merck (Dover, DE)
- …Quality Systems, Medical Devices, Pharmaceutical Process Development, Procurement, Regulations, Regulatory Affairs Compliance, Regulatory Affairs ... position will be part of the Device Quality & Regulatory Team within Global Regulatory Affairs...+ Audit vendors/partners of SaMD/IVD/Companion Diagnostics **Reports to** - Director Regulatory Compliance, Device Quality and … more
- Merck (Dover, DE)
- …Capability, People Leadership, Policy Implementation, Project Management, Project Tasks, Regulatory Affairs Compliance {+ 4 more} **Preferred Skills:** ... **Job Description** ** Director , Combination Product Regulatory CMC -...content or processes may also be required.Provide evaluations of regulatory state of affairs of any devices… more
- United Therapeutics (Dover, DE)
- …or pharma regulatory experience with a Bachelor's Degree in life sciences, quality, regulatory affairs or a related area of study or 10+ years of biologic ... experience with a Master's Degree in life sciences, quality, regulatory affairs or a related area of...in the Company's comprehensive benefits suite of programs, including medical / dental / vision / prescription coverage, employee… more
- Otsuka America Pharmaceutical Inc. (Dover, DE)
- …skilled and experienced Medical Director of CNS Early Assets, Global Medical Affairs , responsible for certain assets within the broader CNS TA portfolio ... CNS Early Assets. **Position Summary:** The Medical Director , Global Medical Affairs , CNS...T1) or early development (phase 1) assets either within Medical Affairs , Regulatory Affairs… more
- Otsuka America Pharmaceutical Inc. (Dover, DE)
- …brand objectives. Work with other relevant internal stakeholders (eg, Brand Teams, Regulatory Affairs , Market Access, Legal, Clinical) to help anticipate, ... We are seeking a Senior Director , Federal Government Affairs to lead...for in a multitude of public policy, legislative, and regulatory regimes and initiatives. Key Responsibilities Serve as the… more
- Grifols Shared Services North America, Inc (Camden, NJ)
- …degree with 2 years of experience. **Pay Scale:** The estimated pay scale for the Medical Affairs Scientific Director 2 role based in the United States ... insights to internal stakeholders 12. Partner with patient advocacy, regulatory , HEOR, and market access to support US and...year. **For California:** The estimated pay scale for the Medical Affairs Scientific Director 2… more
- CSL Behring (King Of Prussia, PA)
- …biotherapies used to treat serious and often rare conditions Could you be our next Director State Government Affairs ? The job is located in the King of Prussia ... around the world are living with rare and serious medical conditions. CSL Behring is committed to delivering medicines...in the northeast. You will report to the Senior Director of State Government Affairs . You will… more
- Canon USA & Affiliates (Dover, DE)
- … Affairs Specialist - Post Market - req1434** **OVERVIEW** Reporting to the Director Regulatory Affairs , the Regulatory Affairs Specialist ... skills, including MS Word, Excel, Oracle, Sales Force, etc. + 2 Years Regulatory Affairs experience in medical device industry required + Minimum Education… more
- American Water (Camden, NJ)
- … regulatory authorities as well as elected and appointed officials. The External Affairs Specialist will report to the Director of Communications and External ... 401(k), Defined Contribution Plan, * Employee Stock Purchase Plan, medical , prescription, dental and vision coverage, plus disability, paid...Affairs Manager in the State and to the Director of External Affairs at corporate. _Key… more
- Penn Medicine (Philadelphia, PA)
- … Regulatory Affairs : Partnership with the Vice Chair for Quality, Medical Director of Ambulatory Operations, and departmental Ops team on Risk Reduction ... alignment with Health System Requirements. In conjunction with the Vice-Chair of Regulatory Affairs , develop programs that enhance the clinical decision-making,… more
- Wolters Kluwer (Philadelphia, PA)
- …device software launches and market expansions. **Post-Market Surveillance and Regulatory Affairs ** + Coordinate post-market activities including surveillance, ... upgrades to prevent future issues . Lead Auditor Certified, preferred . Regulatory Affairs Certification (RAC), preferred. **TRAVEL:** Travel is minimal and… more
- Grifols Shared Services North America, Inc (Newark, DE)
- …and services in more than 110 countries and regions. **Position Overview:** The Medical Director will be responsible for clinical strategy relating to upcoming ... study reports, NDA, etc.) in cooperation with colleagues in Regulatory Affairs and other functions + Serve...disease. **Pay Scale:** The estimated pay scale for the Medical Director (1-2) role based in the… more
- Otsuka America Pharmaceutical Inc. (Dover, DE)
- …to serve as an clinical/ medical scientific consultant to health economic, medical affairs , marketing, regulatory , statistical and other research project ... **Job Description** Otsuka is seeking a Director , Global Clinical Development (GCD), who will be...medical writing. + Complete understanding of the global regulatory requirements. Demonstrated experience in successful regulatory … more
- Bausch + Lomb (Dover, DE)
- …with relevant global team members, other B&L departments (eg, R&D/Project Management, Clinical/ Medical Affairs , Biometrics, Regulatory Affairs , Quality ... in an accurate and timely manner. + Provide Clinical Operations support to the Regulatory Affairs department. Leadership: + Manage in-house team of CRAs, CTAs… more
- University of Pennsylvania (Philadelphia, PA)
- …programs and resources, and much more. Posted Job Title Assistant/Associate Director , Grant and Contract Financial Administration Job Profile Title Associate ... Director D, Business and Finance, Research Services Job Description...stakeholders, research administrators, internal and external partners, sponsors, and regulatory agencies throughout the post award lifespan of a… more
- Merck (Dover, DE)
- …authorities, ethics committees, and internal auditors in conjunction with CCQM, compliance, Regulatory , Pharmacovigilance (PV) and Medical Affairs . + ... **Job Description** The Executive Director (ED) is the Clinical Operations lead in...Clinical Practice (GCP), ICH GCP Guidelines, Leadership, Management Process, Medical Affairs , Mentorship, People Leadership {+ 15… more
- Teleflex (Wayne, PA)
- …of all projects and the overall functional budget. * Ensure the team works with the Regulatory lead and Medical Director to create sound regulatory ... Senior Director , Clinical Evidence Generation (REMOTE) **Date:** Jun 24,...and Business Acumen to lead and develop their Clinical Medical Affairs team to consistently deliver high… more
- University of Pennsylvania (Philadelphia, PA)
- …health and wellness programs and resources, and much more. Posted Job Title Director , Research Operations Job Profile Title Director C, Research Job Description ... alignment with the University of Pennsylvania, GCP, FDA and all applicable regulatory bodies. The candidate must have a comprehensive understanding of clinical trial… more