Average salary: $179,400 /yearly

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Takeda Development Center Americas, Inc. is seeking a Manager, Regulatory Affairs CMC in Cambridge, MA to Develop the Global Regulatory Strategy for products in commercial and development phase; ensure timely submission of new submissions (IND, NDA, BLA, JNDA) to various... 
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Takeda Development Center Americas, Inc

Cambridge, MA
29 days ago
 ...#ForeverCaring and you will do the same. Job Summary: The primary responsibilities of the position are to drive improvements in regulatory affairs processes, systems and infrastructure whilst supporting regulatory strategy and registration across global markets across the... 
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Work from home
Night shift
2 days per week
1 day per week

Convatec Group PLC

Lexington, MA
8 hours ago
 ...medicines to patients through looking at and treating disease in a revolutionary way? What if you could be the first hire in Regulatory Affairs with the opportunity to build a strategy and your team as we expand our clinical pipeline? What this position is all about:... 
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Shift work
3 days per week

Flagship Pioneering, Inc.

Somerville, MA
4 days ago
Responsibilities: Your main tasks will be related to the regulatory aspects of the development or improvement of products, including...  ...s such, you will be interacting not only with your Regulatory Affairs team colleagues but also with members of the R&D, Marketing, and... 
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Katalyst HealthCares and Life Sciences

Boston, MA
2 days ago
 ...Job Title Principal Regulatory Affairs Specialist Job Description Principal Regulatory Affairs Specialist- Software & Artificial Intelligence (U.S. Hub Based) The Principal Regulatory Affairs Specialist- SW & AI will shape, lead and execute innovative regulatory... 
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Philips

Cambridge, MA
3 hours agonew
 ...have you in front of a live recruiter. The Opportunity Description We're looking for an Associate Director of Regulatory Affairs , working in Pharmaceuticals and Medical Products industry in Cambridge, Massachusetts, United States . Works... 
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Flexible hours

PSG Global Solutions Careers

Cambridge, MA
8 hours ago
 ...constituent of the FTSE 100 Index (LSE:CTEC). To learn more about Convatec, please visit Job Summary: In this role as a Senior Regulatory Affairs Specialist at Convatec, you will be responsible for leading regulatory strategy and driving registrations across... 
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Worldwide
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Convatec Group PLC

Lexington, MA
3 days ago
 ...renewal activities for IL-labeled products. Related duties include participation on design and risk management teams, initiation of regulatory plans for both new products and significant product modifications, documentation of regulatory impact from device modifications,... 
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Werfen

Bedford, MA
8 hours ago
 ...Key Accountabilities (Digital Factory Products)Conceive of and Implement the Regulatory Strategy in collaboration with Cross-Functional (Solution Leaders, SBU Marketing, Medical Affairs, BU Regulatory and other) partners. Collaborate with Digital Sol Regulatory Affairs... 
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Instrumentation Laboratory Company

Bedford, MA
8 hours ago
 ...in which human potential is no longer hindered by the burden of disease. Description: Reporting to the Sr. Director of Regulatory Affairs and Policy, this role will support and lead activities within the Regulatory group to advance development of the assets in Wave... 
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Wave Life Sciences

Lexington, MA
8 hours ago
 ...We are seeking an individual who is talented, motivated, and passionate about science to join our Regulatory Strategy team. As Senior Director of Regulatory Affairs, the successful candidate will play an important role in guiding new products into the clinic and setting... 
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Alkermes

Waltham, MA
8 hours ago
 ...Job Description Position Summary: Reporting to the Senior Director, Regulatory Affairs, Advertising, Promotion & Labeling, the Director, Regulatory Affairs, Advertising and Promotion will be responsible for providing sound regulatory advice related to communication... 
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Alkermes

Waltham, MA
1 day ago
 ...boundaries of what is possible 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... 
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Holiday work
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Temporary work
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Takeda Pharmaceutical Company Limited

Boston, MA
8 hours ago
Nova Biomedical is hiring a Regulatory Affairs Specialist (Level II or Senior Level) in our Waltham, MA facility (Hybrid) to focus on assuring company compliance to US 510k, Health Canada Licensing, International Device Submissions, Licensing and Registration requirements... 
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Nova Biomedical

Waltham, MA
1 day ago
 ...have you in front of a live recruiter. The Opportunity Description We're looking for an Associate Director Regulatory Affairs CMC , working in Pharmaceuticals and Medical Products industry in Cambridge, Massachusetts, United States . Leads development... 
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PSG Global Solutions Careers

Cambridge, MA
8 hours ago
 ...The Associate Director of Regulatory Affairs CMC will support development CMC team activities for an emerging portfolio of biologics products. This position will oversee CMC Health Authority submissions, collaborating across the business and with external partners to... 

Keros Therapeutics

Lexington, MA
4 days ago
 ...Director, Regulatory Affairs About the Company Globally recognized biotechnology company Industry Biotechnology Type Privately Held About the Role The Director, Regulatory Affairs will be responsible for developing global regulatory strategies,... 

Confidential

Boston, MA
1 day ago
 ...The Principal Regulatory Affairs Specialist will play a critical role in ensuring our Coronary Vascular products are safe, reliable, and compliant with global regulatory standards through team leadership and providing regulatory guidance for Sustaining and New Product... 
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Philips

Cambridge, MA
8 hours ago
 ...Senior Director, Regulatory Affairs About the Company International labelling organization based in Los Angeles Industry Retail Type Privately Held About the Role The Senior Director, Regulatory Affairs will be responsible for developing and managing... 
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Confidential

Boston, MA
3 days ago
 ...and procedures, to ensure the rapid and successful development and registration of products while maintaining compliance with all regulatory requirements and commitments. Evaluates proposed regulations and advises on impact of such regulations on the company; may... 
Remote job
Contract work
Local area
Night shift

Lantheus Medical Imaging Inc

Bedford, MA
10 days ago