- System One (Tarrytown, NY)
- Regulatory Submission Project Management Specialist Location: Remote Term: 12-month renewable (CONTRACT TO HIRE) Target Pay: $30-$36/HR Must have recent ... PHARMA regulatory experience, preferably working on submissions. The Temp Regulatory Submission Project Management will provide support to the … more
- PNC (Pittsburgh, PA)
- …to prepare data sets for automation, internal stakeholders and regulatory submission *Leverage project management platforms to submit project ... defects, resolve issues, coordinate releases, and test defects/system changes. *Interpret regulatory guidelines and convert into project specifications for data… more
- IQVIA (Durham, NC)
- **Job Level: FSP** **Principal Biostatistician -** **R Regulatory Submission and Multiple Imputations** **Location:** Home-based in the US or Canada **Why ... Phase 2/3 clinical trial experience.** + Demonstrated ability to work independently in project management and decision making. + Able to effectively communicate… more
- Lilly (Indianapolis, IN)
- … process in clinical data trials. + Experience with project management and leading without authority, while influencing submission teams and reporting ... and vendors throughout the submission preparation process and post submission regulatory requests for data. **Process/Technology Strategy Development and … more
- Abbott (Alameda, CA)
- … regulatory outcomes of initial product concepts and provide input to senior regulatory management + Assist in the development of multicountry regulatory ... scientists. + The Opportunity - We are seeking a Regulatory Affairs Project Manager to join our...in the development of relevant data to complete a regulatory submission Preferred Qualifications - + Experience… more
- Abbott (Maple Grove, MN)
- …Change Assessment + International Product Registration support + Ad and Promotional Material - Regulatory Review + Project management skills - organize and ... functional groups in the development of relevant data to complete a regulatory submission . **Preferred** **Qualifications** + Familiarity with Regulatory … more
- Nestle (Denver, CO)
- …team with accountability for submission operational activities and processes, vendor management , project management and negotiation skills; and knowledge ... tasks including file transfer, storing, tracking, and archiving of regulatory submission documents/correspondence. * Provides Regulatory Intelligence… more
- J&J Family of Companies (Raritan, NJ)
- …meetings as appropriate + Understand submission details and collaborate closely with Submission Management + Review and approve submission plans + Review ... the drug development process + Solid understanding of the regulatory submission and approval process + Knowledge...diverse team environment and as an individual contributor + Project management , oral & written communication skills,… more
- J&J Family of Companies (Spring House, PA)
- …Experience leading submission teams and working with external partners. + Project management certification. + Regulatory certification (RAC). + ... individual will serve as the primary project management point of contact to ensure Regulatory ...variations and Pediatric submissions, partnering to ensure alignment of Regulatory and compound submission strategies, developing clear… more
- Corteva Agriscience (Indianapolis, IN)
- …federal guidance to meet compliance requirements and is responsible for the regulatory submission process including preparing documents for the submission ... small teams across portfolio,** to drive label creation and maintenance, address regulatory submission feedback, comply with the federal and state electronic… more