- Canon USA & Affiliates (Boston, MA)
- **Mgr Regulatory Affairs Sr - req1224** **OVERVIEW** Manages the day to day activities of the Regulatory Affairs (RA) pre-market group. Responsible ... for pre-market and post-market activities as assigned by the Director, Regulatory Affairs to include new product planning and remedial actions on released… more
- Harvard University (Cambridge, MA)
- …protected by law.Job Summary:The Senior Manager for Intergovernmental Policy and Regulatory Affairs for Harvard Public Affairs and Communications (HPAC) ... and its operations. The Senior Manager for Intergovernmental Policy and Regulatory Affairs brings significant knowledge of state and municipal regulatory… more
- AbbVie (Boston, MA)
- …and procedures and accepted standards of best practice. This role is considered remote but requires the employee to work within a reasonable distance from the ... patient or compassionate use basis, subject to all applicable legal and regulatory requirements. + Must provide insights on the current clinical practice, facilitate… more
- Elevance Health (Woburn, MA)
- …and tactical issues. + Work collaboratively with other teams, including legal, compliance, regulatory affairs , in supporting the business. + In a complex and ... **Associate General Counsel Sr . - Pharmacy** **Location:** This position will work a hybrid model ( remote and office). The ideal candidate will live within 50… more
- Astellas Pharma (Westborough, MA)
- ** Regulatory Manager, Regulatory Affairs - CMC (Gene Therapy)** Do you want to be part of an inclusive team that works to develop innovative therapies for ... Term Incentive Plan for eligible positions + Referral bonus program \#LI-TR1 Category Regulatory Affairs CMC Astellas is committed to equality of opportunity in… more
- Takeda Pharmaceuticals (Boston, MA)
- … Affairs SOPs and processes. + Coordinate with Pharmacovigilance, Quality and Regulatory Affairs to respond to external audits and requests from external ... role:** You will manage the operational conduct of Medical Affairs Company Sponsored Studies (MACS), Investigator Initiated Research (IIR)... regulatory bodies. + Manage the pre-fair market value (FMV)… more
- RELX INC (Cambridge, MA)
- …relevant to global policy development (for example public policy, international affairs , regulatory compliance, knowledge management). Experience with content ... in an industry (for example, a financial institution) and/or regulatory capacity and proven research, analysis and writing skills....of leadership. + Research and analysis experience. + Global affairs knowledge. + Any of the following would be… more
- Fresenius Medical Center (Waltham, MA)
- …device manufacturing industry or pharmaceutical industry. Experience in quality assurance, regulatory affairs , compliance preferred. + 3+ years of experience ... Position can be remote , must be willing to travel PURPOSE AND...is consistently applied across global sites and validated/verified per regulatory requirements. + Deploy and maintain the global quality… more
- CVS Health (Boston, MA)
- …This is a remote based from from home role. The Medical Affairs department provides clinical business support to the entire enterprise and provides clinical ... a share of special clinical investigations and research as requested by the Senior Medical Director, Medical Affairs . These projects can include brief reviews… more
- Takeda Pharmaceuticals (Lexington, MA)
- …potential issues. POSITION ACCOUNTABILITIES: + Collaborate with colleagues in Regulatory Affairs , Medical, Legal, Commercial, and Compliance organizations ... **Job Description** About the role: Join Takeda as a Senior Manager, US Medical Ad/Promo Regulatory Review... regulatory requirements. + Understand broad concepts within Regulatory Affairs and potential effects across the… more
- Takeda Pharmaceuticals (Boston, MA)
- …area of regulatory strategy such as understanding broad concepts within regulatory affairs and implications across the organization and globally; proactively ... life-changing therapies to patients worldwide. Join Takeda as a Senior Director, Global Regulatory Lead, GI &...regulatory strategy such as understanding broad concepts within regulatory affairs and implications across the organization… more
- Astellas Pharma (Westborough, MA)
- …operations, revenue, and/or credibility. **Organizational Context:** Reports to Director or Senior Director, Regulatory Affairs CMC. **Qualifications:** ... www.astellas.com . This position is based in Westborough, MA. Remote work from certain states may be permitted in...position plays a key global leadership role in the Regulatory Affairs department for the Chemistry, Manufacturing… more
- Edwards Lifesciences (Boston, MA)
- …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 ... with principal investigators, dedicated medical professionals, patient advocacy groups, and regulatory authorities, you will drive the evidence needed to optimize… more
- Takeda Pharmaceuticals (Boston, MA)
- …Operations at Takeda will be responsible for formulating and implementing the Global Regulatory Affairs Operations (GRA-Ops) vision and strategy to achieve a ... all regulatory sites/functions. + Serve as a member of the Global Regulatory Affairs Leadership Team, influencing the operations and future strategy of the… more
- Takeda Pharmaceuticals (Lexington, MA)
- …of proposed promotional and disease state materials. + Collaborate with Regulatory Affairs , Medical, Legal, Commercial, and Compliance, execute and ... and compliance with regulatory requirements. + Understand broad concepts within Regulatory Affairs and potential effects across the organization. Identify … more
- Merck (Boston, MA)
- …Work closely with a cross-functional group of experts in commercialization, regulatory affairs , statistics, and manufacturing to manage clinical development ... **Job Description** The ** Senior Clinical Director ( Sr . Principal Scientist)**...pursue and subsequent study design, initiation, execution, monitoring, analysis, regulatory filing, and publication. **Specifically, The Senior … more
- Takeda Pharmaceuticals (Boston, MA)
- …and alignment of the labeling strategy and labeling content. Interface with Senior Management Cross-Functional Team (GLOC) + In alignment with TAU/MPD Labeling Lead, ... coordinates the process to obtain labeling approval by Labeling Senior Management Cross-functional team (Global Labeling Oversight Committee - GLOC) driving… more
- Takeda Pharmaceuticals (Boston, MA)
- … management to plan, evaluate and recommend implementation strategy. As part of the Regulatory Affairs CMC team, you will report to the Executive Director and ... life-changing therapies to patients worldwide. Join Takeda as a Senior Director, GRA CMC Pharmaceuticals Development Portfolio Lead where...Head, CMC Regulatory Affairs - Pharmaceuticals. **How you will… more
- Commonwealth Care Alliance (Boston, MA)
- …guidance, direction, and practical translation of privacy requirements (legal, regulatory , contractual and, as applicable, those emanating from national ... direct and indirect reports, and may have dotted line and/or regulatory /governance oversight responsibility of other relevant areas. **Supervision Exercised:** +… more
- Guardian Life (Boston, MA)
- …We drive a high-performance culture across our Legal, Compliance, and Government Affairs functions, aligned to "what" we deliver (ie, our goals and objectives) ... Legal Compliance Team? This role will be primarily responsible for providing regulatory compliance support and monitoring of the Guardian Group Benefits Product,… more