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 ...company, focused on solutions for the management of chronic conditions, with leading positions...  ...position are to drive improvements in regulatory affairs processes, systems and infrastructure...  ...; * Serve as regulatory liaison on project team throughout the product lifecycle;... 
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ConvaTec

Lexington, MA
4 days ago
 ...more details on our portfolio. Job Description The Manager, Regulatory Affairs provides regulatory support for oncology products in early...  ...will support the regulatory lead on program related projects and be responsible for interacting with multiple functions... 
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Deciphera Pharmaceuticals

Waltham, MA
3 days ago
 ...products while maintaining compliance with all regulatory requirements and commitments. Evaluates...  ...this level, the incumbent independently manages a major segment of the Company's...  ...ensuring regulatory documentation meets project target dates. Executes compilation of... 
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Lantheus

Bedford, MA
2 days ago
 ...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...  ...; further global experience would be a plus. * Experience managing external teams at CROs and driving execution against key deliverables... 
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Flagship Pioneering, Inc.

Somerville, MA
3 days ago
 ...Job Title Principal Regulatory Affairs Specialist Job Description Principal Regulatory...  ...identify risks within regulatory strategies, project plan, and outline proposal for...  ...risks to projects and the regulatory management team. Lead regulatory submission activities... 
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Philips

Cambridge, MA
4 days ago
 ...looking for an Associate Director of Regulatory Affairs , working in Pharmaceuticals and Medical...  ...strategic regulatory leadership to project teams in early and late stage clinical...  ...Excellent organizational and project management skills; demonstrated ability to prioritize... 
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PSG Global Solutions Careers

Cambridge, MA
4 days ago
 ...Related duties include participation on design and risk management teams, initiation of regulatory plans for both new products and significant product...  ...Excellent analytical and strategic thinking skills Strong project management skill Cross-cultural project experience... 
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Werfen

Bedford, MA
4 days ago
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 ...Job Description Job Description Job Description Manager, Global Regulatory Affairs About This Role The Global Regulatory Affairs...  ...and marketed products. You are a member of the Regulatory Project Team for assigned programs and work with direction from... 
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Biogen

Cambridge, MA
3 days ago
 ...Responsibilities: Responsible to communicate new regulatory guidelines. Lead the strategic efforts in the...  .... Provide support to Regulatory CMC managers in developing strategy for development projects, including assigned projects and back-up projects.... 
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Katalyst Healthcares & Life Sciences

Boston, MA
3 days ago
Nova Biomedical is hiring a Regulatory Affairs Specialist (Level II or Senior Level) in our...  ...approval of ECOs related to assigned projects Participate in Quality System Audits...  ...preferred ~ Statistics and data base management proficiency preferred Certified... 
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Nova Biomedical

Waltham, MA
22 hours ago
 ...The Sr. Regulatory Affairs Specialist will lead activities which support both domestic and international regulatory registrations and submissions activities including data and information analysis. Additionally, the ideal candidate will provide regul Specialist, Medical... 
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Insulet

Acton, MA
4 days ago
 ...worldwide. Join Takeda as a Director, Regulatory Affairs Vaccines CMC where you will provide...  ...contribute: Lead planning, execution, and management of regulatory submissions for assigned...  ...meetings on CMC topics. Ensure project team colleagues, line management, and... 
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Takeda Pharmaceutical Company Limited

Boston, MA
4 days ago
 ...for patients.   The Position Manage and oversee all assigned projects/products/processes. Assist the...  ...submission of any required documents to regulatory agencies.   Relationships Report to a Director of Regulatory Affairs. Develop and maintain positive... 
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Novo Nordisk

Lexington, MA
3 hours agonew
 ...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
4 days ago
 ...hydrogel-based medical devices. Their commitment to self-funding projects, strategic partnerships, and innovative technology...  ...excellence in healthcare solutions! The Role As the sole Regulatory Affairs Manager, you'll lead the charge in ensuring compliance with... 
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2 days per week

Pragmatic

Bedford, MA
1 day ago
 ...Description We're looking for an Associate Director Regulatory Affairs CMC , working in Pharmaceuticals and Medical Products industry...  ...clinical development, registration, and product life cycle management Manages timely regulatory submissions that involve CMC... 

PSG Global Solutions Careers

Cambridge, MA
4 days ago
 ...for a Full Time Senior Vice President, Regulatory Affairs and Quality to lead regulatory...  ...quality systems for cutting-edge biotech projects at Beacon Therapeutics. As a pivotal member...  ...submission, and part of the executive management team reporting to the CEO. At Beacon... 
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Beacon Therapeutics (USA) Inc

Cambridge, MA
2 days ago
 ...Vice President of Regulatory Affairs About the Company Leading biopharmaceutical firm specializing in oncology therapeutics...  ...interpersonal and organizational skills, and the ability to manage multiple project objectives within set timelines. A comprehensive... 

Confidential

Boston, MA
1 day ago
 ...Senior Director, Regulatory Affairs About the Company International labelling organization...  ...be responsible for developing and managing labeling for products worldwide as well...  ...and negotiations for assigned labeled projects. Travel Percent Less than 10%... 
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Confidential

Boston, MA
2 days ago
 ...Great QA/RA Project Management opportunity with a well-established and growing developer of a range of specialized medical temperature sensing...  ...all aspects of a new product lines compliance with all Regulatory, Clinical and QA technical, clinical and marketing requirements... 
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Client of Nachman BioMedical

Waltham, MA
2 days ago