- Mitsubishi Chemical Group (Jersey City, NJ)
- …real-world evidence, and creating hope for all facing illness. The Senior Director , Regulatory Affairs - Clinical (Neuroderm), may be called upon to ... facilitate timely drug development and registration. The Senior Director , Regulatory Affairs - Clinical also works directly with cross-functional project… more
- Merck (Rahway, NJ)
- …The GRACS Global Process Lead (GPL) is responsible for overseeing and managing Global Regulatory Affairs & Clinical Safety (GRACS) global business processes. ... + Complete Impact assessment on new or changed external regulatory policies as it pertains to the processes that...the organization, including managing the impact of final external regulatory policies that support work that is executed in… more
- Mitsubishi Chemical Group (Jersey City, NJ)
- …researching on real-world evidence, and creating hope for all facing illness. The Director , Regulatory Affairs (Early Development) provides strategic global ... requests, meeting requests, and briefing documents. + Acts as liaison between Regulatory Affairs and other functional areas, including external contractors (eg,… more
- Kelly Services (Alameda, CA)
- ** Regulatory Affairs Policy, Intel, & Compliance Director ** + Direct Hire + Location: Alameda, CA or King of Prussia, PA + The base pay range: $183,000 - ... maintain processes and procedures, in response to changes in regulatory requirements. Oversees Regulatory Affairs ...the Kelly Talent Community. Why Kelly (R) Science & Clinical ? Kelly Science & Clinical is your… more
- Ascendis Pharma (Palo Alto, CA)
- …a dynamic workplace for employees to grow and develop their skills. The Associate Director , Regulatory Affairs will be responsible for developing and ... and regulatory colleagues. + Contributes to the development of global clinical regulatory plans and strategies, identifies, and proposes risk mitigation… more
- Taiho Oncology (Princeton, NJ)
- Associate Director , Regulatory Affairs Operations Pleasanton, CA, USA * Princeton, NJ, USA Req #386 Tuesday, August 20, 2024 Looking for a chance to make a ... expanding mid-size oncology company in the role of Associate Director , Regulatory Affairs Operations where...customers such as: Clinical , Biostats, Legal, Medical Affairs , Commercial, Pharmacovigilance and regulatory vendors +… more
- Gilead Sciences, Inc. (Foster City, CA)
- …worldwide, with headquarters in Foster City, California. **About the Role:** The Senior Director , CMC Regulatory Affairs for Biologics is responsible for ... by maintaining the global licensures. In addition, the Sr Director will be accountable for leading the interpretation and...process in close partnership with other functions in PDM, Regulatory Affairs , and Clinical Development.… more
- Veterans Affairs, Veterans Health Administration (Ann Arbor, MI)
- …who receive care at VAAAHS and its CBOCs. Incumbent works closely with Public Affairs , clinical service lines, Homeless Program staff, OEF/OIF program staff and ... This position is located in the Office of the Director and is under the direct supervision of the...and is under the direct supervision of the Public Affairs Officer. Responsibilities OUTREACH COORDINATOR- Development and Implementation of… more
- Abbott (Alameda, CA)
- …diversity, working mothers, female executives, and scientists. **The Opportunity** This **Associate Director Regulatory Affairs - APAC** will work on-site ... Division. As a manager, the function of an Associate Director Regulatory Affairs , APAC (Asia...Provide guidance for resource and development planning + Approve regulatory filing strategies based upon proposed preclinical, clinical… more
- Danaher Corporation (Raleigh, NC)
- … Affairs department and report to the Vice President of Global Quality and Regulatory Affairs . The Director of Global Regulatory Affairs ... human health. This position is part of Quality and Regulatory Affairs located in Fargo, ND and...+ Primary liaison for communications with FDA and other regulatory authorities associated with clinical and commercial… more
- GE HealthCare (FL)
- …market requirements. + Leads a team of regulatory professionals in execution of regulatory affairs tasks in support of the businesses. + Prepares global ... of regulatory professionals, this position provides strategic regulatory leadership to the Consumables ( Clinical Accessories)...pharmaceuticals, or biologics. + A minimum of 5 years Regulatory Affairs / Quality Assurance experience. +… more
- Stryker (San Jose, CA)
- …(https://d25zu39ynyitwy.cloudfront.net/oms/000000/document/2024/6/SMVZW\_USStrykerEmployeebenefits/USStrykerEmployeebenefits.pdf) The ** Director , Regulatory ... Through close partnership with business unit leadership, Marketing, R&D, Clinical and Quality teams, the Director will...Provide a strategic direction and tactical focus to the Regulatory Affairs organization and influence the direction… more
- Philips (Cambridge, MA)
- **Senior Director of Clinical Affairs **...on clinical evidence topics eg evaluation of clinical and regulatory risk, investments, etc. + ... topics to support strategy development and strategy execution. + Build Clinical Affairs , Market Access and outcomes research capability and governance… more
- AbbVie (Florham Park, NJ)
- …Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn. Job Description The Director Regulatory Affairs , Strategic Labeling is responsible for ... or Microbiology + Preferred Education: Relevant Master's degree preferred. Certification in regulatory affairs a plus + Required Experience: 10+ years… more
- Boehringer Ingelheim (Ridgefield, CT)
- …to five (3-5) years of experience in the pharmaceutical industry with experience in Regulatory Affairs . + Manager level: must have (1-3) years of experience in ... Knowledge and understanding of drug development, including phases of clinical studies, general requirements for drug marketing approval and...the pharmaceutical industry, preferably in Regulatory or Medical Affairs . + Specific experience… more
- AbbVie (Irvine, CA)
- …the key regulatory contact for Quality, Medical Safety and International Regulatory Affairs colleagues. + Provides regulatory policy, intelligence ... Follow Allergan Aesthetics on LinkedIn. Job Description The Associate Director of Regulatory Innovation supports regulatory...of global submissions. Directs and supports development of the regulatory strategy with a focus on Clinical … more
- Regeneron Pharmaceuticals (Basking Ridge, NJ)
- The Director Regulatory Affairs will provide leadership on global regulatory activities for the assigned products. Responsibility will mainly focus on ... Clinical Regulatory filings and provide regulatory leadership on the project teams in this area. We are a hands-on culture so responsibilities will include… more
- Abbott (Lake Forest, IL)
- …desired. + Prior experience in medical device and thorough knowledge of clinical research and/or regulatory affairs preferred + Experience ... Preferred **Experience/Background** + Minimum 10 years Progressive work experience in regulatory affairs or a related discipline in the medical device field. +… more
- BeiGene (San Mateo, CA)
- …met while leveraging expedited pathways where appropriate. The individual will have regulatory affairs and cross-functional influence within the solid tumor ... The Executive Director , Solid Tumor North America Lead will be...on projects including, but not limited to, North America regulatory strategies, regulatory requirements for clinical… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …throughout the product's lifecycle and across different indications. + Represent Global Regulatory Affairs on the GPT (Global Project Team), Daiichi Sankyo ... decision-maker and/or arbitrator on global projects. + Interface with clinical and pre- clinical groups, Regulatory ...pharmaceutical industry + 7 or more years with direct regulatory affairs experience + Experience in … more