- 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
- Teva Pharmaceuticals (West Chester, PA)
- Manager , CMC Regulatory Affairs -...as a result of an agency referral where no pre -existing agreement is in place. Where agency agreements are in ... people to make a difference with. **How you'll spend your day** As Manager , CMC Regulatory Affairs you will be responsible for managing the day-to-day… more
- AbbVie (Irvine, CA)
- …Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn. Job Description The Manager , Regulatory Affairs In Vitro Diagnostics and Companion ... implements, and documents policies and procedures within the regulatory affairs department under supervision of manager . Participates in initiatives internal… more
- Novo Nordisk (Lexington, MA)
- …documents to regulatory agencies. Relationships Report to a Director of Regulatory Affairs . Develop and maintain positive rapport and working relationships ... with other personnel in Regulatory Affairs and other local and headquarter...Write Regulatory documents translating team strategy into regulatory overview documents such as cover letters, pre… more
- Astrix Technology (Houston, TX)
- Global Regulatory Affairs Manager II Regulatory Affairs Houston, TX, US Pay Rate Low: 65.00 | Pay Rate High: 75.72 + Added - 08/03/2024 Apply for Job ... in the world - with complementary businesses in Surgical and Vision Care. **Global Regulatory Affairs Manager II** 55.00-72.75 9 Month Contract with… more
- Novo Nordisk (Plainsboro, NJ)
- …Relationships Report to the Director/Associate Director/Lead Regulatory Scientist/Sr. Manager Regulatory Affairs . Develop and maintain positive ... rapport and working relationships with other personnel in Regulatory Affairs , CMR, and other local and...pre -BLA) for review by Project Leaders + Write Regulatory documents translating team strategy into regulatory … more
- Medtronic (Santa Rosa, CA)
- …Rosa, CA or Mounds View, MN. Careers that Change Lives Reporting to the Senior Manager , the Principal Regulatory Affairs Specialist will support Research and ... Principal Regulatory Affairs Specialist - Structural Heart...Development programs with early phase pre -market regulatory strategy development with a view… more
- GE Vernova (Wilmington, NC)
- …working groups. Occasional travel is required. The role is in Regulatory Affairs and reports to the General Manager of Nuclear Programs. **Job Description** ... **Job Description Summary** The New Plant/Product (NPP) Licensing Manager will establish the vision & strategy and...establish the vision & strategy and drive execution for Regulatory Affairs to accelerate the licensing needed… 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 ,...for eligible health care and dependent care expenses with pre -tax dollars. + Tuition : Take advantage of Penn's… more
- System One (Florham Park, NJ)
- Title: Manager /Senior Manager US Regulatory Affairs - Global Development Projects Location: Remote Type: Contract Rate: 52-70 (DOE) Start Date: ASAP ... located in NJ is hiring a Manager /Senior Manager US Regulatory Affairs -...strategies for multiple clinical development projects at all stages ( Pre -IND through NDA submission and approval). + Support and… more
- Mitsubishi Chemical Group (Jersey City, NJ)
- …evidence, and creating hope for all facing illness. The Senior Director, Commercial Regulatory Affairs , is responsible for the development and execution of the ... US and Canada. In addition, the Senior Director, Commercial Regulatory Affairs , in collaboration with Head, ...interactions with US FDA, OPDP and Health Canada for regulatory related activities by drafting pre -meeting briefing… more
- Bausch Health (Bothell, WA)
- …aesthetic care options to consumers and physicians alike. Reporting to the Sr Dir, Global Regulatory Affairs , the Sr Manager , Regulatory Affairs ... regulatory agencies through oral and written communications regarding pre -submissions strategies, potential regulatory pathways, compliance test requirements,… more
- Bausch Health (Bothell, WA)
- …proven and effective aesthetic care options to consumers and physicians alike. The Manager , Regulatory Affairs provides direct support to Solta operations ... related field. + Should have over 7 years of experience as Sr. Regulatory Affairs Specialist. + Should have experience of independently authoring complete… more
- Edgewell Personal Care Brands, LLC (CT)
- …work instructions and standard operating procedures. Assists with the training of regulatory affairs personnel and provides direction on specific projects. ... responsibility for one or more colleagues. **Accountabilities** + Design and implement Regulatory Affairs strategies, policies and objectives in accordance with… more
- Black Hills Energy (Denver, CO)
- Regulatory Affairs Manager (relocate to Denver!) Location: Denver, CO, United States Job ID: 35148 Date Posted: Mar 22, 2024 Salary: $ 110900 to $ 183100 ... to e-mail Apply Now > Job Description Job Specifications Manage all regulatory matters for assigned state(s) or jurisdiction(s) to achieve the company's business… more
- Medtronic (Boston, MA)
- …affairs OR + An advanced degree with 2+ years of experience in regulatory affairs **Nice to Have** + Experience in Pre -Sub, IDE, 510(k), De Novo, or PMA; ... SENIOR REGULATORY AFFAIRS SPECIALIST - Digital Technologies...computer, and communicate with peers and co-workers. Contact your manager , recruiter or local HR to understand the Work… more
- Medtronic (Northridge, CA)
- …employees in more than 160 countries. **A Day in the Life** As Principal Regulatory Affairs Specialist, you will develop and implement medical device ... from worldwide regulatory bodies. Working with global Regulatory Affairs colleagues, you will ensure submissions...level. All significant issues will be reviewed with the manager . + Maintain proficiency in global regulatory … more
- Medtronic (Boston, MA)
- …own your future success. Together, we can transform healthcare. The Senior Director of Regulatory Affairs will lead the Regulatory team for Medtronic's ... be required. This role reports to the Vice President, Regulatory Affairs for the Surgical Operating Unit...Collaborate with R&D and Clinical to determine and execute pre -clinical/clinical test plans in support of regulatory … more
- BeiGene (Emeryville, CA)
- …and execute in the preparation of timely responses to small molecule CMC regulatory questions, pre -meeting packages, and interactions with Heath Authorities as ... **General** **Description:** BeiGene is seeking an experienced and energetic regulatory professional to manage, evaluate, and complete regulatory projects… more
- Regeneron Pharmaceuticals (Troy, NY)
- …and global RA in a timely manner * Review the content and format of regulatory filing documents (eg pre -INDs, INDs, IMPDs, BLAs, MAAs, BPDRs, annual reports, ... The candidate will support the development and execution of regulatory strategies for biologic products and combination products for the portfolio assigned and… more