- Teva Pharmaceuticals (West Chester, PA)
- Director Regulatory Affairs - Submission ...Project Manager , a key member of Global Regulatory Affairs , will be responsible to develop ... This role requires utilization of in-depth knowledge of global regulatory submission requirements, processes and procedures, eCTD... Team and dossier timelines. + Accountable to Global Regulatory Lead and Global Regulatory Affairs… more
- STERIS (St. Paul, MN)
- …documents. Utilizes electronic record-keeping tools according to departmental policy. The Senior Regulatory Affairs Manager is expected to have in-depth ... Senior Manager , Regulatory Affairs Biocides...STERIS's global business plans. This includes determining registration and submission requirements in the various markets and identifying the… more
- Actalent (Maryland Heights, MO)
- …will rely on the Canadian RA staff for country-specific regulations. The Senior Manager Regulatory Affairs will directly participate in project teams ... need experience working with cross functional teams. The Senior Manager of Regulatory Affairs is...mentor less experienced staff on Risk-Based Decision making. Skills: Regulatory affairs , Regulatory submission… more
- Abbott (Plymouth, MN)
- …people to restore their health and get on with their lives. **The Opportunity** The Regulatory Affairs Manager will work out of either our Plymouth, St. ... As a manager , the function of a Manager Regulatory Affairs is to... submission filing. Compile, prepare, review and submit regulatory submission to authorities. + Evaluate risk… more
- Abbott (Des Plaines, IL)
- …and proteins at the molecular level. As a manager , the function of a Manager Regulatory Affairs is to combine knowledge of scientific, regulatory ... submission filing. Compile, prepare, review and submit regulatory submission to authorities. + Evaluate risk...is recognized as a discipline expert and resource in regulatory affairs . + Influence/Leadership: . Develops, communicates,… more
- ICU Medical (Lake Forest, IL)
- …and will not be discriminated against on the basis of disability. **Title:** * Regulatory Affairs Manager * **Location:** *IL-Lake Forest* **Requisition ID:** ... Job Title Manager , Regulatory Affairs -...when necessary. Review technical reports and determine acceptability for regulatory submission . * Identify registration documentation deficiencies,… more
- AbbVie (Irvine, CA)
- …https://global.allerganaesthetics.com/. Follow Allergan Aesthetics on LinkedIn. Job Description Description The Manager Regulatory Affairs represents US ... Lead (GRL) and project team. Plans and prepares complex regulatory submission documents primarily for US ...in a scientific field, plus 6 years' experience in regulatory affairs ; or + Education equivalent to… more
- Teva Pharmaceuticals (West Chester, PA)
- Manager , CMC Regulatory Affairs -...and Responses to FDA information requests. Assist in the submission of regulatory correspondence to the FDA. + ... a difference with. **How you'll spend your day** As Manager , CMC Regulatory Affairs you...timelines in order to judge the work required for submission of a quality filing + Ability to assess… more
- Teva Pharmaceuticals (West Chester, PA)
- Senior Manager , Regulatory Affairs (Remote) Date: May 2, 2024 Location: West Chester, United States, Pennsylvania, 19380 Company: Teva Pharmaceuticals Job ... make a difference with. **The opportunity** As the Senior Manager , Regulatory Affairs you will...and Responses to FDA information requests. Assist in the submission of regulatory correspondence to the FDA.… more
- Mitsubishi Chemical Group (Jersey City, NJ)
- …submission packages, labeling revisions, and promotional materials for regulatory compliance. In addition,collaborateswith Medical Affairs regarding ... evidence, and creating hope for all facing illness. The Senior Director, Commercial Regulatory Affairs , is responsible for the development and execution of the… more
- BD (Becton, Dickinson and Company) (San Diego, CA)
- **Job Description Summary** As Manager , Regulatory Affairs , you will provide leadership to the MMS -Pharmacy Automation platform team. You will contribute to ... pre-market regulatory leadership to MMS-PA business + Directs premarket regulatory affairs activities which may include interactions between MMS-PA and… more
- ADM (Kennesaw, GA)
- **83651BR** **Job Title:** Senior Regulatory Affairs Manager - Kennesaw, GA **Department/Function:** Legal, Compliance, Regulatory Affairs , Corporate ... a full-time, exempt level position. **Position Summary:** The Senior Regulatory Affairs Manager is responsible...actions as applicable. + Own the preparation, review and submission of regulatory dossiers and applications for… more
- ICON Clinical Research (Farmingdale, NY)
- …and the friendliest people in the sector, and you'll be helping shape an industry. ** Regulatory Affairs Manager - In Vitro Diagnostic (IVD) Medical Devices** ... **The role:** As a Regulatory Affairs Manager you will...in the context of early phase drug development, providing regulatory strategy, regulatory writing and submission… more
- Stryker (Portage, MI)
- …quality products and solutions in a timely manner. We are currently seeking a ** Manager , Regulatory Affairs , State Licensing** to join our **Corporate** ... an onsite role based in **Portage, Michigan.** **What you will do** **The Manager , Regulatory Affairs , State Licensing, Designated Representative** works… more
- Lauridsen Group Inc. (Ankeny, IA)
- The Senior Manager of Regulatory Affairs plays a crucial role in ensuring Proliant Health & Biologicals (PHB) products comply with local and international ... teams, and stakeholders to develop and implement regulatory strategies. The Senior Manager of Regulatory Affairs is responsible for leading and managing… more
- Abbott (Pleasanton, CA)
- …working mothers, female executives, and scientists **The Opportunity** We are seeking a ** Regulatory Affairs Manager ** to join Abbott's Heart Failure ... CA. As an individual contributor, the function of a Regulatory Affairs Manager is to...emerging issues. + Lead functional groups to complete a regulatory submission . + Regulatory history,… more
- Philips (San Diego, CA)
- **Senior Regulatory Affairs Manager (US Hub based location)** The Senior Regulatory Affairs Manager will develop and communicate a vision for the ... of regulatory submissions. You will manage a Regulatory Affairs team supporting various new and...13485 and QSR registrations. Experience with successful preparation and submission of Technical Documentation, 510(k). + You have a… more
- Entergy (Austin, TX)
- Manager , Regulatory Affairs (Utility) **Date:** Apr 20, 2024 **Location:** Austin, Texas, United States **Company:** Entergy **Posting End Date:** **Work ... in an effective manner is essential. + Review all regulatory agency submission materials to ensure timeliness,...candidates for work visas for this position. **Job Segment:** Regulatory Affairs , Compliance, Law, Marketing Manager… more
- dsm-firmenich (Princeton, NJ)
- Senior Regulatory Affairs Manager , Pharma North America Location: Plainsboro, NJ Hybrid As Senior Regulatory Affairs Manager , Pharma within the ... approval in collaboration with R&D, product and project management, and regional regulatory affairs teams. Coordinate the submission of dossiers to the… more
- University of Pennsylvania (Philadelphia, PA)
- …duties relevant to regulatory affairs as assigned. DUTIES: Reporting to the Regulatory Affairs Manager , the Regulatory Affairs Specialist ... coordination of Phase I-V clinical trials. Reporting to the Regulatory Affairs Research Teams Manager ,... Specialist is expected to facilitate the development and submission of FDA IND applications and annual reports, and… more