- Amneal Pharmaceuticals (Piscataway, NJ)
- …Associate II (A), assists with minimal guidance, the Senior Director of Regulatory Affairs Clinical / FDA Communications.Assists the Senior Director ... updates Essential Functions: + Assist the Senior Director of Clinical Regulatory Affairs / FDA Communications in managing, coordinating, tracking and… 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
- Amgen (Washington, DC)
- …over 10 million patients worldwide. It's time for a career you can be proud of. ** Regulatory Affairs Director - Global Regulatory Leader - Oncology** ... this. Let's change the world. Amgen is seeking a Regulatory Affairs Director supporting products...precedent + Lead the planning and implementation of global regulatory filings (eg clinical trial applications, marketing… more
- BD (Becton, Dickinson and Company) (San Diego, CA)
- **Job Description Summary** The Sr. Director , Regulatory Affairs is the ranking Regulatory Affairs leader for the Infusion Process Excellence RA ... provides expertise and leadership to business partners, the Assoc Director of Process Excellence Regulatory Affairs... issues for staff and for business stakeholders (eg, Clinical , R&D., Marketing) + In conjunction with RA business… more
- Ascendis Pharma (Princeton, NJ)
- …committed to working together as one team to achieve extraordinary results. The Associate Director Regulatory Affairs , Advertising and Promotion will be an ... governing the promotion of prescription drug and biologic products. The Associate Director Regulatory Affairs , Advertising and Promotion is responsible… more
- Amgen (Washington, DC)
- …Amgen team. Join us and transform the lives of patients while transforming your career. ** Regulatory Affairs Director - Global Regulatory Lead** **What ... this. Let's change the world. Amgen is seeking a Regulatory Affairs Director supporting products...precedent + Lead the planning and implementation of global regulatory filings (eg clinical trial applications, marketing… more
- West Pharmaceutical Services (Exton, PA)
- Director , Regulatory Affairs , Intelligence Requisition ID: 67704 Date: Oct 23, 2024 Location: Exton, Pennsylvania, US Department: Regulatory Affairs ... healthier environment and planet through our sustainability efforts. **Job Summary:** + The Director , Regulatory Affairs , Intelligence is expected to perform… 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
- Gilead Sciences, Inc. (Foster City, CA)
- …liver diseases, cancer and inflammation, and serious respiratory and cardiovascular conditions. ** Director , CMC Regulatory Affairs - Biologics** **Key ... Responsibilities:** The Director , CMC Regulatory Affairs for Biologics is responsible for...process in close partnership with other functions in PDM, Regulatory Affairs , and Clinical Development.… more
- Merck (Philadelphia, PA)
- …accountable, global regulatory point of contact on those projects within Global Regulatory Affairs and Clinical Safety (GRACS) and external to GRACS. ... **Job Description** The Regulatory Affairs Headquarters Principal Scientist is...clinical experience, preference if this experience is in regulatory affairs . + Excellent communication skills (both… 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 (Chicago, IL)
- … 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
- J&J Family of Companies (Horsham, PA)
- Johnson & Johnson is recruiting for an Associate Director , CMC Regulatory Affairs . This position can be located in Spring House, PA; Horsham, PA; Titusville, ... of the product and is in alignment with the strategies of global regulatory affairs , the therapeutic area, commercial, regional functions and the Quality… 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
- Stryker (Fremont, CA)
- …sources and partners with other functions such as Clinical Operations, Medical Affairs , Regulatory Affairs and Marketing to obtain regulatory ... Stryker employee benefits. (https://d25zu39ynyitwy.cloudfront.net/oms/000000/document/2024/6/SMVZW\_USStrykerEmployeebenefits/USStrykerEmployeebenefits.pdf) The ** Director , Global Clinical Evidence and Medical Affairs ** provides direction… more
- AbbVie (South San Francisco, CA)
- …technologies to discover and develop novel cancer treatments. We are currently seeking a Regulatory Affairs Director to join our growing regulatory ... sub-teams + Develop and implement competitive and effective global regulatory strategies for oncology products including clinical ,...preferred. + 8 - 12 years of experience in Regulatory Affairs (strong preference for experience in… 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
- Regeneron Pharmaceuticals (Tarrytown, NY)
- 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
- BeiGene (Emeryville, CA)
- …healthcare regulatory matters across business functions, including commercial, clinical development, medical affairs , patient safety, legal, and healthcare ... **General Description:** Reporting to the Head of Regulatory , Advertising/Promotion, this role provides regulatory oversight, and strategic guidance on… 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