- 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
- 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
- Commonwealth Care Alliance (Boston, MA)
- …(eg, Claims, Credentialing, Clinical Care Management, Member Services, Provider Services, Regulatory Affairs , Marketing) to resolve provider issues and reduce ... with other CCA departments, including Clinical Management, Member Services, Claims, Regulatory Affairs , Outreach and Marketing, to resolve provider issues.… more
- CSL Behring (Waltham, MA)
- **Position Title:** Senior Manager , Corporate & External Affairs , R&D Portfolio **Position Purpose:** The Senior Manager , Corporate and External Affairs , ... R&D Portfolio will execute the corporate and external affairs strategy for CSL's pipeline. The successful candidate will...partners. + Act as a supporting partner to the regulatory policy team providing input on advocacy opportunities, and… more
- 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
- 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
