- Chiesi (Cary, NC)
- Global Regulatory Affairs Labeling...group to be awarded **B Corp Certification** , a recognition of **high social and environmental standards.** We are ... & Promotional Manager Date: Jan 23, 2025 Department: Global Regulatory Affairs Job Type:...other departments and/or affiliates as appropriate. + Interact with senior management, external departments and health authorities as needed… more
- Lilly (Indianapolis, IN)
- …risk, and improve efficiency in drug development. The purpose of the Associate Vice President - Global Regulatory Affairs , Global Regulatory Policy & ... and regulatory excellence attributes as described in Global Regulatory Affairs white papers...guided by industry norms and business strategy + Influence senior leadership, regulators, and/or external partners on business and… more
- Danaher Corporation (Fargo, ND)
- …of Global Quality and Regulatory Affairs . The Director of Global Regulatory Affairs will be responsible for developing and executing ... human health. This position is part of Quality and Regulatory Affairs located in Fargo, ND and...ensuring accuracy, completeness, and timeliness. + Monitor and interpret global regulatory requirements and trends, provide strategic… more
- Takeda Pharmaceuticals (Boston, MA)
- … Affairs CMC team, you will report to the Senior Director Global Regulatory Affairs CMC. **How you will contribute:** + Independently plan, execute ... meetings, international experience preferred. + Understanding of scientific principles and regulatory CMC requirements relevant to global drug development and… more
- AbbVie (North Chicago, IL)
- …you will be added to our talent pipeline and considered for future opportunities. Global Regulatory Affairs Strategy roles (US and Canada) are: 1. ... HA requirements. 6. Responsible for products within a Therapeutic Area & support the Global Regulatory Lead (GRL) & Therapeutic Area Head with the development &… more
- Takeda Pharmaceuticals (Columbus, OH)
- …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… more
- Lilly (Indianapolis, IN)
- …for market registrations and post-approval submissions. The regulatory scientist in Global Regulatory Affairs - CMC Biotechnology will leverage CMC ... knowledge of CMC drug development science(s) + Knowledge of CMC global regulatory requirements and guidelines related to parenteral drug product manufacturing… more
- Astrix Technology (Los Angeles, CA)
- …innovative clients who specializes in the Nutraceutical space is seeking a Sr . Regulatory Affairs Specialist ( Global ) to help expand portfolio. This is a ... ** Regulatory Affairs Specialist ( Global )** Regulatory Affairs Los Angeles County, CA, US Pay Rate Low: 65 | Pay Rate High: 80 + Added - 15/10/2024… more
- Olympus Corporation of the Americas (Center Valley, PA)
- …an entity other than @Olympus.com, it is likely not legitimate._ **Job Description** The Senior Specialist, Regulatory Affairs Operations - Regulatory ... facilitating the activities described by a global regulatory intelligence process. **Job Duties** The Senior ... regulatory intelligence process. **Job Duties** The Senior Specialist, Regulatory Affairs Operations… more
- Lilly (Indianapolis, IN)
- …and enable effective decision-making related to molecule development. + Consult on global regulatory strategy, advise on IND/CTA content including gap analysis ... opportunities to evolve how Lilly and LRL operates. The ** Senior Director** is responsible for managing all Regulatory...college or university + At least 5 years of regulatory affairs experience with research-based drug development,… more
- Fresenius Medical Center (College Park, GA)
- …AND SCOPE:** Assists in the support of the daily operational activities within Regulatory Affairs for the preparation of regulatory submissions required ... RESPONSIBILITIES:** + A seasoned, experienced professional with a full understanding of Regulatory Affairs ; resolves a wide range of issues in creative ways. +… more
- Gilead Sciences, Inc. (Foster City, CA)
- … data requirements, drives data quality initiatives, and facilitates alignment between global regulatory affairs and cross-functional teams. The role ... in a matrixed environment. + Experience in leading high-complexity, large-scale, cross-functional global initiatives in regulatory affairs . + Certifications… more
- Teleflex (Maple Grove, MN)
- …candidate is required to work effectively with cross- functional virtual groups and global regulatory affairs contacts to maintain worldwide Regulatory ... Regulatory Affairs Specialist **Date:** Jan 10,...candidate is also responsible for staying abreast of evolving global regulatory requirements. **Principal Responsibilities** * Develop… more
- BD (Becton, Dickinson and Company) (San Diego, CA)
- …preferred + RAPS RAC certification preferred + Six Sigma desired + Knowledge of global Regulatory Affairs requirements, regulations and standards + Strong ... address some of the most challenging global health issues. The Director of Regulatory Affairs reports directly to the Senior Director of Regulatory … more
- ThermoFisher Scientific (Rochester, NY)
- …and pharmaceutical services through our industry-leading brands. Position Summary Lead the global Regulatory Affairs (RA) team and provide organizational ... for talent development within the team. Reporting to the Senior Director of Regulatory Affairs ,...compliance within LPE. Responsible for leading and developing the global RA team supporting LPE. Responsible for reviewing and… more
- BD (Becton, Dickinson and Company) (San Diego, CA)
- …experience including SaMD/SiMD experience + Project Management experience + Knowledge of global Regulatory Affairs requirements, regulations, and standards + ... **Job Description Summary** As Sr . Manager of Regulatory Affairs...Devices along with associated Software and Accessories on a global basis from a Regulatory Affairs… more
- Sumitomo Pharma (Columbus, OH)
- …position of **Director Regulatory Affairs ** . The Director is part of the Global Regulatory Affairs (GRA) team based in the US. He/she will primarily ... function as the Regional Regulatory Leader (RRL) and/or Global ...pharmaceutical industry with minimum of 8 years focused in regulatory affairs . + Master's degree required (preferably… more
- Gilead Sciences, Inc. (Parsippany, NJ)
- …Regulatory Advertising and Promotion (RA Ad/Promo) is a core function within Gilead's Global Regulatory Affairs organization and acts as a critical ... colleagues. You may initiate and/or contribute to local or global process improvements for activities relating to the work...Experience working with external contractors supporting the work of regulatory affairs is a plus. + Experience… more
- Gilead Sciences, Inc. (Foster City, CA)
- …will include, but are not limited to the following:** + Interns will assist the Global Regulatory Affairs Oncology Liaison team with projects to support ... etc.). + In addition, the intern work across the global regulatory network on various research projects...college + Must be a Rising Sophomore, Junior, or Senior in undergrad or a Graduate or Doctoral Student… more
- AbbVie (North Chicago, IL)
- … and Medical Affairs Quality Standards is responsible for the management of a RDQA global Safety, Regulatory Affairs (RA) and Medical Affairs (MA) QA ... including but not limited to Pharmacovigilance and Patient Safety, Regulatory Affairs and Medical Affairs ...regulatory requirements. Proactively monitor and interpret the external global regulatory environment for regulatory … more