- Repligen (Waltham, MA)
- …as neededMaintains regulatory compliance through continuous monitoring of International regulatory standards (eg WHO, EMA, FDA , ISO)Develops & maintains ... OverviewThe Senior Director, Global Regulatory Affairs will report directly to the VP,...learning curves and the opportunity to contribute to the healthcare of patients worldwide. All of this with an… more
- AUROBINDO (Durham, NC)
- …the accuracy of analytical measurements and compliance with cGMP, US FDA , and other regulatory and corporate requirements.Conducting troubleshooting and ... and validation, with prior supervisory roles being advantageous.Familiarity with pharmaceutical regulatory standards, including USP/ICH/ FDA 21 CFR 210/211, CFR… more
- Merck & Co. (Rahway, NJ)
- …or design controls areaKnowledge of US and global medical device and healthcare regulations, including FDA combination products cGMP, Quality System Regulation, ... from early design concept definition through commercialization to support regulatory filing, product launch, and post-market surveillance.This position will interact… more
- Tris Pharma (Monmouth Junction, NJ)
- …to strategy discussions in cross functional settingsExperience interacting with the FDA and other regulatory organizationsHands-on experience with statistical ... accuracy and integrity, contributing to research protocol development and supporting regulatory submissions. Provides expert statistical input in design and analysis… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …within the organization. From health-care-provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education ... About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one...days per week in our Plainsboro, NJ location. Qualifications Healthcare degree required; RN/NP/PharmD/PhD/MD preferred; 1 year of relevant… more
- Lundbeck (Greensboro, NC)
- … regulatory environment, including Lundbeck policies and procedures and FDA regulations regarding the promotion of pharmaceutical and medical products. Ability ... to apply knowledge of overall healthcare economy and industry practices. Accountability and adherence to corporate, FDA , and PDMA guidelines.REQUIRED EDUCATION,… more
- AUROBINDO (Durham, NC)
- …with expertise in manufacturing, R&D, Quality Assurance and Quality control and regulatory affairs. In addition to several formulations under manufacture, we have a ... robust pipeline of products. Aurolife's aim is to provide healthcare at economical prices to make this a healthier...under the direction of a supervisor.8. Comply with all regulatory /in-house requirements (may include but not limited to safety,… more
- Lundbeck (College Station, TX)
- …Environment/Compliance - Ability to apply knowledge of pharmaceutical and regulatory environment, including accountability and adherence to Lundbeck policies and ... procedures and FDA regulations regarding the promotion of pharmaceutical and medical...years pharmaceutical, biopharmaceutical, biologics, medical device sales or related healthcare sales experience Must demonstrate the intellectual capacity to… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …QA experience Experience in a licensed drug or biologic facility regulated by the FDA , EMEA or a leading international regulatory agency preferred As applicable, ... Reviews and assesses Corrective and Preventive Action Reports Participates in Regulatory Inspections Other duties as assigned Performs all job duties and… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …the following is desired: Microsoft Windows Operating Systems and Networking systems (Ethernet) FDA and EMEA Regulatory requirements Experience at a medium to ... in a compliant and ethical manner and in accordance with all applicable healthcare laws, regulations and industry codes Incorporates the Novo Nordisk Way and 10… more
- Lundbeck (Oakland, CA)
- …Environment/Compliance - Ability to apply knowledge of pharmaceutical and regulatory environment, including accountability and adherence to Lundbeck policies and ... procedures and FDA regulations regarding the promotion of pharmaceutical and medical...years pharmaceutical, biopharmaceutical, biologics, medical device sales or related healthcare sales experience Must demonstrate the intellectual capacity to… more
- Kelly Services (Gillette, WY)
- …and launching a state-of-the-art research laboratory dedicated to shaping the future of healthcare . As a **Senior FDA Regulatory Affairs Specialist** , ... regulatory teams to meet safety and efficacy standards. ** Regulatory and Compliance Expertise:** + Lead FDA ...experience in regulatory affairs, product development, or FDA submission leadership in a healthcare or… more
- Regeneron Pharmaceuticals (Sleepy Hollow, NY)
- …development through commercialization, including advising on a broad range of healthcare regulatory matters, including labeling negotiations, advertising and ... industry, including product development, commercialization, and the legal and regulatory environment (including healthcare fraud and abuse, anti-kickback,… more
- Rush University Medical Center (Chicago, IL)
- …engineering program, including vendor oversight. Strong knowledge of Joint Commission, CMS, FDA , and other healthcare regulatory standards. Experience with ... management of biomedical equipment. Ensure compliance with The Joint Commission, CMS, FDA , and other regulatory requirements. Lead and manage relationships with… more
- BeiGene (San Mateo, CA)
- …**Essential Functions of the job:** + Uses extensive knowledge of the US FDA regulatory environment and the ability to apply knowledge both strategically ... and advice on FDA interactions. + Oversees the preparation of NA regulatory documentation and ensures timelines are met, including the review of NA submission… more
- Houston Methodist (Houston, TX)
- …study team and sponsor's regulatory team. This position communicates with regulatory affairs office for FDA submissions across multiple studies of different ... **SERVICE ESSENTIAL FUNCTIONS** + Ensures compliance of general and study-specific regulatory and/or safety-related processes with SOP's, FDA , GCP, NIH… more
- J&J Family of Companies (Spring House, PA)
- …plans including BLA/NDAs, IND/CTAs & supplements. + Serve as primary point of contact for US FDA + Lead the regulatory response team for FDA and Health ... Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where...Experience leading interactions with Health Authorities is required. + FDA and Global regulatory experience is required.… more
- IQVIA (Falls Church, VA)
- …in both the guidance and the practice of developing strategies and evidence to engage US FDA , the EMA and other regulatory agencies on COA endpoints and the use ... and consortia + Lead development of IQVIA's responses to public consultation processes from FDA and other regulatory agencies relating to PED + Contribute to the… more
- Takeda Pharmaceuticals (Boston, MA)
- …**Job Description** **Associate Director, US Advertising & Promotion Regulatory Review** **Takeda Pharmaceutical** **USA-MA-Virtual** **About the role:** Join ... Takeda as an Associate Director, US Advertising & Promotion Regulatory Review where you will be working on the...be empowered to serve as an internal expert on FDA regulations, guidance, and enforcement trends governing the promotion… more
- BD (Becton, Dickinson and Company) (San Diego, CA)
- … affairs, with a focus on medical device systems + Knowledge of international regulatory requirements (eg, FDA QSR, ISO 13485, IEC 62304) + Solid understanding ... Experience working with regulatory submissions, interactions with regulatory agencies (eg, FDA , BSI or other...and effective problem-solving, which are essential in the fast-paced healthcare industry. For most roles, we require a minimum… more
