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 ...Manage and oversee all assigned projects/products/processes. Assist the Director/ Associate Director in assuring Novo Nordisk compliance...  ...compilation and submission of any required documents to regu Regulatory Affairs, Manager, Regulatory, Manufacturing, Business Services,... 
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Novo Nordisk A/S

Lexington, MA
1 day ago
 ...Together, we are leading the way towards a healthier and more equitable future. Position Summary As the Senior Manager of Regulatory Affairs, you will play a critical role in ensuring regulatory compliance and supporting the execution of our regulatory strategy... 
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Flexible hours

Editas Medicine

Cambridge, MA
2 hours ago
 ...Job Description About the Job The Regulatory Affairs (RA) Director is responsible for the development and implementation of a comprehensive...  ...innovative global strategy. External Relationship Management: Establish strong partnerships and relationships with... 
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Work experience placement

Foundation Medicine, Inc.

Boston, MA
1 day ago
 ...Job Description - Regulatory Affairs Coordinator I (3285805) Regulatory Affairs Coordinator I - ( 3285805 ) The Alzheimers Clinical...  ...Director, the Regulatory Affairs Coordinator will assist the management team to ensure that regulatory requirements are met for all... 
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Massachusetts General Physicians Organization

Boston, MA
2 days ago
Job TitlePrincipal Regulatory Affairs SpecialistJob DescriptionPrincipal Regulatory Affairs Specialist- Software & Artificial Intelligence...  ...balancing the project risks to projects and the regulatory management team.Lead regulatory submission activities, and directly interact... 
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Philips

Cambridge, MA
2 days ago
 ...to propose and implement solutions. Identifies different strategies for addressing issues; advises of risk/benefit of each and assists clients with making sound bus Regulatory Affairs, Manager, Regulatory, Advertising, Product Development, Business Services, Medical... 
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Sanofi, Inc.

Cambridge, MA
2 days ago
 ...registration of products while maintaining compliance with all regulatory requirements and commitments. Evaluates proposed regulations...  ...company's interests. At this level, the incumbent independently manages a major segment of the Company's regulatory effort and serves... 
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Lantheus

Bedford, MA
1 day ago
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 ...Description We're looking for an Associate Director of Regulatory Affairs , working in Pharmaceuticals and Medical Products...  ...able to meet deadlines Excellent organizational and project management skills; demonstrated ability to prioritize multiple projects... 
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PSG Global Solutions Careers

Cambridge, MA
3 days 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
3 days ago
 ...registration and 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... 
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Worldwide

Werfen

Bedford, MA
3 days ago
 ...Title: Director, Global Regulatory Affairs, Oncology Company: Ipsen Bioscience, Inc. Job Description: Director, Global Regulatory...  ...options proactively proposed for project team and senior management decision making. Accountable for the flawless execution... 
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Ipsen Pharma

Cambridge, MA
3 days ago
 ...they will mainly fall within the areas of Pharmaceutical, Biotechnology or Biologics Regulatory Affairs This individual will prepare, compile, and submit CT/IND/MAA I NOA, manage and implement label review, translation requirements, fee requirements, and may... 
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Katalyst Healthcares & Life Sciences

Cambridge, MA
2 days ago
 ...Nova Biomedical is hiring a Regulatory Affairs Specialist (Level II or Senior Level) in our Waltham, MA facility (Hybrid) to focus on assuring...  ...experience is preferred * Statistics and data base management proficiency preferred Certified Quality Auditor and RAC Certification... 
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Nova Biomedical

Waltham, MA
2 days ago
 ...Senior Director, Regulatory Affairs Dragonfly Therapeutics is seeking a Senior Director, reporting directly to the Senior Vice President...  ...program teams. Alignment with all stakeholders, including senior management, is crucial. This role combines strategic and operational... 
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Dragonfly Therapeutics

Waltham, MA
4 days ago
 ...studies, including vimseltinib and DCC-3116. See here for more details on our portfolio. Job Description The Manager, Regulatory Affairs provides regulatory support for oncology products in early- and late-stage development. In this role, the Manager of Regulatory... 
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Deciphera Pharmaceuticals

Waltham, MA
7 days ago
 ...therapies to patients worldwide. Join Takeda as a Director, Regulatory Affairs Vaccines CMC where you will provide program leadership and...  ...How you will contribute: Lead planning, execution, and management of regulatory submissions for assigned vaccines in various phases... 
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Takeda Pharmaceutical Company Limited

Boston, MA
3 days 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
3 days ago
 ...pharmaceutical industry in the development and manufacturing of new treatments for patients worldwide. Your talents, ideas, and passion are essential to our mission: to Regulatory Affairs, Director, Associate, Regulatory, Product Development, Business Services, Compliance... 
Worldwide

Catalent, Inc.

Chelsea, MA
22 hours ago
 ...Job Description Job Description Job Description Manager, Global Regulatory Affairs About This Role The Global Regulatory Affairs Manager, works closely with Global and Regional Regulatory Leads providing support for a variety of regulatory activities for... 
Local area

Biogen

Cambridge, MA
7 days ago
 ...Promotion (USAP) will provide strategic regulatory advice to internal stakeholders regarding...  ...with colleagues in Commercial, Medical Affairs, Legal, Compliance and other expertise areas...  ...and information •Experienced in managing individuals and/or teams preferred Ways... 
Flexible hours

Alnylam Pharmaceuticals

Cambridge, MA
2 days ago