- Lundbeck (MA)
- … Affairs colleagues (Medical Directors, Medical Excellence, Clinical Development, Global Medical, etc.) to execute therapeutic area strategy and tactics Liaise ... be their best. Inspired and driven by our purpose, we are the only global biopharmaceutical company focused solely on brain diseases. We have a robust and innovative… more
- Sanofi Group (Cambridge, MA)
- …the advertising and promotion of prescription drugs and biologics. Essential Functions + Represents Global Regulatory Affairs (US RA AdPromo) as a member of ... About the Role The Associate Director , US Regulatory Affairs ...Consults with senior management and provides input to the global organization as needed. + Contributes US RA AdPromo… more
- Sanofi Group (Cambridge, MA)
- …and Capabilities** + This individual is expected to competently and confidently represent Regulatory Affairs as a key member of cross-functional RC teams for ... The Associate Director RA serves as the regulatory lead on Review Committees (RCs). As the RC RA representative, work with brands on competitively positioning… more
- Gilead Sciences, Inc. (Boston, MA)
- …Description Regulatory Affairs Labeling is a core function within Gilead's Global Regulatory Affairs organization and acts as a critical strategic ... will be filled as a Senior Manager or Associate Director , based on candidate experience. **REQUIREMENTS:** We are all...of current global and regional trends in regulatory affairs and is able to apply… more
- Medtronic (Boston, MA)
- …you need to own your future success. Together, we can transform healthcare. The Senior Director of Regulatory Affairs will lead the Regulatory team ... technologies to market. It involves creating, managing and executing global regulatory strategies for new product development...be required. This role reports to the Vice President, Regulatory Affairs for the Surgical Operating Unit… more
- Takeda Pharmaceuticals (Boston, MA)
- …in order to bring life-changing therapies to patients worldwide. Join Takeda as a Director , Regulatory Affairs Vaccines CMC where you will provide program ... leadership and develop CMC regulatory strategy for global vaccine programs in...various stages of development. You will represent the vaccine regulatory affairs team on cross-functional Takeda Vaccines… more
- Bausch Health (Boston, MA)
- …and procedures to enhance efficiencies and compliance. + Works closely with the Regulatory Affairs labeling group regarding package insert changes to assess and ... Bausch Health is a global company that develops, manufactures, and markets a...and the ability to see business drivers outside of regulatory affairs + Working knowledge of the… more
- ConvaTec (Lexington, MA)
- …analyses, and generation of publications. You will have close liaison with Clinical Affairs , Global Education, Regulatory , Quality, Marketing & Business ... to improve the lives we touch: Convatec is a global medical products and technologies company, focused on solutions...grow while honing your strategic thinking skills Our successful Director /Senior Manager Medical Affairs will be involved… more
- Novo Nordisk (Lexington, MA)
- …of any required 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... landscapes to maintain current knowledge + Work with Global Regulatory Lead and team to draft… more
- Pfizer (Cambridge, MA)
- …and understand the point of view of patients and HCPs. Working closely with Global Medical Affairs and cross-functional colleagues, s/he ensures that the US ... **ROLE SUMMARY** The Senior Medical Director will be responsible for leading several US...tactics and ensure the delivery of these plans + Global Medical Affairs Team Meetings: + Participate,… more
- Philips (Cambridge, MA)
- … regulatory files and tracking databases as required. + Reporting to the Director of Regulatory Affairs - Coronary Vascular you will collaborate with ... The Principal Regulatory Affairs Specialist will play a...Coronary Vascular products are safe, reliable, and compliant with global regulatory standards through team leadership and… more
- Philips (Cambridge, MA)
- …body audits. Implements internal or external quality system audits. + Reporting to the Director of Regulatory Affairs , the Senior RA Specialist will ... (AMI) solutions are safe, reliable, and compliant through driving global regulatory strategy and regulatory ...for earliest possible approvals of clinical trials applications. + Regulatory Affairs representative for the CT/AMI Systems… more
- Pfizer (Cambridge, MA)
- …medical affairs and cross-functional US Vyndaqel/Vyndamax team(s). The medical director will support key internal and external medical initiatives such as ... **ROLE SUMMARY** The Medical Director will provide leadership and expertise in Transthyretin...patients and physicians point of view. Works closely with Global Medical Affairs and cross-functional colleagues to… more
- Takeda Pharmaceuticals (Boston, MA)
- …, Global Regulatory Project Management, GI 2 within our Global Regulatory Affairs organization, based remotely. **_OBJECTIVES/PURPOSE_** + Partners ... with the Global Regulatory Lead (GRL) on ...the pharmaceutical industry and drug development project management and regulatory affairs (eg, clinical development, the prescription… more
- Olympus Corporation of the Americas (Westborough, MA)
- … regulatory agencies regarding compliance issues. Directs the development of global regulatory communication processes to include responses to external audits ... by applicable federal, state or local law. Posting Notes: || United States (US) || Massachusetts (US-MA) || Westborough || Quality & Regulatory Affairs (QA/RA) more
- Editas Medicine (Cambridge, MA)
- …will be responsible for: + Provide CMC expertise in the Editas regulatory affairs organization by keeping abreast of global CMC regulatory requirements ... required and advanced degree preferred with a minimum of 10 years' experience in drug development/ regulatory affairs and a minimum 8 years in CMC regulatory … more
- Cardinal Health (Boston, MA)
- …of capacities, including: + Global Regulatory Strategy Development + Global Regulatory Affairs + Chemistry Manufacturing and Controls Development + ... brand for post-approval success in obtaining the greatest market share possible. The Director , Business Development with Cardinal Health Regulatory Sciences is a… more
- Sanofi Group (Cambridge, MA)
- …in regulatory policy efforts. Reporting through Region North America within Global Regulatory Affairs (GRA), the candidate will work collaboratively ... to have a positive impact on the environment advise internal stakeholders on evolving regulatory policy issues, and more! The Director will be a strong subject… more
- Sanofi Group (Cambridge, MA)
- …pharmaceutical/biotechnology industry experience, including at least 4 years of relevant Regulatory Affairs experience (regionally and/or global ) especially ... the US regulatory post-marketing activities. + As a key member of the Global Regulatory Team (GRT), and strategic partner to the Global Regulatory … more
- Sanofi Group (Cambridge, MA)
- …pharmaceutical/biotechnology industry experience, including at least 4 years of relevant Regulatory Affairs experience (regionally and/or global ) especially ... + Leads the US regulatory activities. + As a key member of the Global Regulatory Team (GRT), and strategic partner to the Global Regulatory Lead… more
