- ThermoFisher Scientific (Waltham, MA)
- …food is safe or helping find cures for cancer. **Discover Impactful Work** As a Sr. Manager , Regulatory Affairs , you will play a crucial role in interpreting ... you will actively contribute to continuously developing and aligning our regulatory tools, including information systems, with our strategic objectives. You will… more
- Dentsply Sirona (Waltham, MA)
- …business relationships. + Manages day to day activities for less senior Regulatory Affairs professionals, including but not limited to mentoring, coaching, ... Education: + Bachelor's degree in a relevant field, such as life sciences, regulatory affairs , or a related discipline. + Regulatory Certification (such as… more
- Otsuka America Pharmaceutical Inc. (Boston, MA)
- …with 5+ years' experience or Master's degree with 2 years' experience in regulatory affairs or related areas (eg, clinical development, project management, ... **Position Summary** Provides critical support in developing global regulatory strategy, planning and execution of global investigational and marketed prescription… more
- Otsuka America Pharmaceutical Inc. (Boston, MA)
- **Job Summary** The Chemistry, Manufacturing and Controls (CMC) Global Regulatory Affairs (GRA) professional is responsible for developing and executing global ... with other local and/or global functional units [OPC CMC Global Regulatory Affairs , Global Regulatory Strategy, Manufacturing facilities, Global Quality,… more
- Cardinal Health (Boston, MA)
- **_What Regulatory Affairs contributes to Cardinal Health_** Regulatory provides regulatory affairs and product development consulting services to ... submissions as well as clinical research and manufacturing process consulting. Regulatory Affairs plans, coordinates and implements regulatory strategies… more
- Bristol Myers Squibb (Cambridge, MA)
- …more: careers.bms.com/working-with-us . **Position Summary** The Director of Early Precision Medicine Regulatory Affairs leads global regulatory strategy for ... Solid scientific background, PhD., MD, PharmD, MS + Significant experience in regulatory affairs and diagnostic-related development eg, >8-10 years. + Scientific… more
- Parexel (Boston, MA)
- Join us as a **Global Labeling Operations Manager ** , where you'll work alongside a large, dedicated client team to drive impactful labeling operations across global ... DE, AU) and non-US/Central EU markets, ensuring compliance with global regulatory requirements and supporting cross-functional teams in delivering accurate, timely,… more
- Boston University (Boston, MA)
- **SENIOR FINANCIAL REPORTING ANALYST, FINANCIAL AFFAIRS , Comptroller's Office** **Job Description** **SENIOR FINANCIAL REPORTING ANALYST, FINANCIAL AFFAIRS , ... in a university environment. + Deep understanding of GAAP and other regulatory standards required for the higher education industry. + Experience creating… more
- Wolters Kluwer (Waltham, MA)
- … and compliance considerations into product strategy and development. **It is not a Regulatory Affairs , PRRC, or Quality role and does not carry regulatory ... ** Regulatory Initiatives Product Manager ** Wolters Kluwer...accountability** . The role works in close partnership with Regulatory Affairs , Quality, Legal, Privacy, and Security… more
- Dana-Farber Cancer Institute (Boston, MA)
- …clinical trials start-up, active and close-out phases + Proficient knowledge of regulatory affairs , research ethics and the responsible conduct of research ... Reporting to the CTIP Associate Director for the Pediatric unit, the Regulatory Operations Manager (ROM) will oversee the CTIP Regulatory Unit, manage the… more
- Takeda Pharmaceuticals (Boston, MA)
- …order to bring life-changing therapies to patients worldwide. Join Takeda as Senior Manager , Global Regulatory Labeling Strategy where you will be responsible ... negotiations with Health Authorities. + Ensures labeling content conform to regulatory requirements. Management of Local Exceptions and LOC Interactions + Manages… more
- Cisco (Boxborough, MA)
- …in the US. **Meet the Team** You will be joining our Supply Chain Regulatory team which drives compliance strategy and governance across Global Supply Chain. You ... capabilities to meet evolving needs. + Engage across Supply Chain, Legal, Government Affairs , Tax and Trade teams to interpret and manage trade regulations + Assess… more
- Otsuka America Pharmaceutical Inc. (Boston, MA)
- The Senior Manager , External Engagement Strategic Planning will play a critical role in shaping and executing strategic initiatives that enhance the impact of ... Medical Affairs external stakeholder engagement activities (including those of the...Compliance and Legal to ensure all engagement strategies meet regulatory and ethical standards. **Cross-Functional Collaboration** + Work close… more
- Otsuka America Pharmaceutical Inc. (Boston, MA)
- …product strategy and scientific messaging. + Collaborate cross-functionally with Medical Affairs , Regulatory , Legal, and Commercial teams to ensure consistency ... The Manager , Medical Core Content is a team-level operational...Act as key support resource for the Field Medical Affairs team, managing the content repository and version control… more
- Sanofi Group (Cambridge, MA)
- …Adobe Acrobat technology is required. **Qualifications:** + Bachelor's degree, or equivalent, in regulatory affairs , the sciences, or related areas of study. + ... **Job Title:** Global Submission Manager **Location:** Morristown, NJ **About the Job** The...years of experience in the pharmaceutical industry, with direct regulatory affairs experience. + High degree of… more
- Fresenius Medical Center (Lawrence, MA)
- …desirable + Strong collaboration skills and experience working with Clinical, Medical Affairs , and Regulatory teams. + Proven ability to develop clinically ... **PURPOSE AND SCOPE:** The ** Manager , HCP Marketing** is responsible for developing and executing clinically focused marketing strategies to support the education,… more
- Wolters Kluwer (Waltham, MA)
- …The Principal SaMD TPM acts as a bridge between engineering, product, regulatory affairs , clinical, and quality assurance teams, facilitating strategic ... The **Principal SaMD Technical Program Manager ** plays a pivotal role in driving the...**Cross-Functional Collaboration:** Act as a liaison between engineering, product, regulatory affairs , clinical, and QA teams to… more
- State of Massachusetts (Boston, MA)
- …manager filings are properly reviewed and addressed within statutory and regulatory timeframes. * Coordinate Pharmacy Benefit Manager Oversight staff ... of Insurance ("DOI"), an Agency within the Office of Consumer Affairs and Business Regulation, administers the Commonwealth's insurance consumer protection laws… more
- Medtronic (Newton, MA)
- …workflow and product knowledge. + Collaborate with cross-functional teams, including R&D, regulatory affairs , and clinical teams, to ensure alignment on quality ... extraordinary. Join Medtronic as a **Software Reliability Engineering Program Manager - Quality Core Team Member** and be at...a relevant field. + Certification in quality systems or regulatory affairs (eg, Six Sigma, ASQ, or… more
- Edwards Lifesciences (Boston, MA)
- …Provide medical writing expertise and collaborate with cross functional teams including Regulatory Affairs , Biostatistics, R&D, QA and Marketing on clinical data ... and how our products transform patients' lives. As part of our Clinical Affairs team, you'll hone your scientific curiosity and passion for evaluating data to… more