- 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
- Chiesi (Boston, MA)
- …Promotional Material/External Communications Responsibilities: + Work in the Global Rare Diseases, Regulatory Affairs Ad Promo function for the United States, ... departments to ensure product risks are appropriately communicated. + Provide training to Regulatory Affairs and other departments as appropriate. + Review and… 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
- IQVIA (Boston, MA)
- ** Manager , Medical Affairs Strategy** **Overview** IQVIA is a leading global provider of advanced analytics, technology solutions, and clinical research services ... practice Principals and other IQVIA teams to strengthen the Manager 's Medical Affairs and consulting expertise. +...life sciences companies. Expertise in domains adjacent to medical affairs , such as regulatory or pharmacovigilance, would… 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
- Medtronic (Boston, MA)
- …connected, compassionate world. **A Day in the Life** The Director, US State Government Affairs will serve as a key member of Medtronic's US Government Affairs ... activities in a multi-state region and reporting to the Head of US Government Affairs . While the territory may fluctuate over time, this role currently covers the… 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
- Parexel (Boston, MA)
- If you are passionate about regulatory affairs and project management, and are looking for a challenging and rewarding opportunity, we would love to hear from ... dedicated client partnership and play a pivotal role in their regulatory affairs department. Key Responsibilities: Collaborative Coordination: Work closely… 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
- Brockton Hospital (Brockton, MA)
- …and technologies for data analysis. This position requires experience in healthcare compliance, regulatory affairs , or a related field, a strong understanding of ... the general supervision of the Vice President of Quality Resources, the Manager of Regulatory Compliance is responsible for overseeing organizational activities… 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 + ... management. Reporting to the CTIP Associate Director for Reg 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
- Takeda Pharmaceuticals (Lexington, MA)
- …candidates pursuing an advanced degree such as a Master's in Life Sciences, PharmD, Regulatory Affairs (Degree or Certification), JD, or MBA are encouraged to ... basic understanding of scientific principles + Ability to understand broad concepts within Regulatory Affairs + Ability to proactively identify regulatory … more
- Otsuka America Pharmaceutical Inc. (Boston, MA)
- The Manager , Contracts (Non-HCP SOWs) is an important role within the Medical Excellence & Operations team within Global Medical Affairs . This role is ... for end-to-end management of contracts that support Global Medical Affairs operations, excluding those with healthcare professionals or organizations. This… 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