Regulatory Affairs Associate Jobs in Massachusetts

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354 Massachusetts Regulatory Affairs Associate jobs found on Monster.

Jobs 1 to 20 of 354
Company: Takeda Pharmaceuticals, Cambridge MA Type: Full-time, Permanent ACCOUNTABILITIES: - Oversees as well as executes all regulatory activities of multiple projects including one highly complex project in development and/or supports regulatory activities for assigned marketed product(s) of responsibility. - Manages direct reports to support scope of project work. - Provides a regulatory s...
Description Genzyme has pioneered the development and delivery of transformative therapies for patients affected by rare and debilitating diseases for over 30 years. We accomplish our goals through world-class research, collaboration with the global patient community, and with the compassion and commitment of our employees. With a focus on rare diseases and multiple sclerosis, we are dedicated to...
Associate/Specialist Regulatory Affairs Publisher & Operations (Needham, MA) Overview: Celldex is looking for an individual with experience in publishing documents for regulatory submissions. The ideal candidate will assist in the day-to-day regulatory operations activities such as; archiving and organizing the publishing logistics for IND safety report submissions, IND monthly submissions, and ...
Description Genzyme has pioneered the development and delivery of transformative therapies for patients affected by rare and debilitating diseases for over 30 years. We accomplish our goals through world-class research, collaboration with the global patient community, and with the compassion and commitment of our employees. With a focus on rare diseases and multiple sclerosis, we are dedicated to...
Description Genzyme has pioneered the development and delivery of transformative therapies for patients affected by rare and debilitating diseases for over 30 years. We accomplish our goals through world-class research, collaboration with the global patient community, and with the compassion and commitment of our employees. With a focus on rare diseases and multiple sclerosis, we are dedicated ...
Description enzyme has pioneered the development and delivery of transformative therapies for patients affected by rare and debilitating diseases for over 30 years. We accomplish our goals through world-class research, collaboration with the global patient community, and with the compassion and commitment of our employees. With a focus on rare diseases and multiple sclerosis, we are dedicated t...
Description Genzyme has pioneered the development and delivery of transformative therapies for patients affected by rare and debilitating diseases for over 30 years. We accomplish our goals through world-class research, collaboration with the global patient community, and with the compassion and commitment of our employees. With a focus on rare diseases and multiple sclerosis, we are dedicated ...
Publish document packages for electronic regulatory submissions, in support of active and planned investigational (e.g., INDs, CTAs) and marketing applications (e.g., NDA, BLA, MAA); will include publishing of documentation from various departmental functions Apply knowledge of electronic publishing requirements to ensure compliance with agency submission requirements on a global basis Rem...
Dyax is a biopharmaceutical company focused on the development and commercialization of products for unmet medical needs while creating value for patients, employees and shareholders. We are driven by one unifying factor which is to improve the lives of patients. We currently market a product for the treatment of acute attacks of hereditary angioedema (HAE), a rare genetic disease. We also have an...
Contract Analytical Services Lab Seeking Regulatory AffairsProject Manager Scope: Jordi Labs is an investigative laboratory which is seeking an experienced regulatory specialist to fill a role in project management and inside sales. Jordi has a 30 year history and a strong established customer base. This position includes fielding customer analysis inquiries for testing services and ongoing acc...
Dyax is a biopharmaceutical company focused on the development and commercialization of products for unmet medical needs while creating value for patients, employees and shareholders. We are driven by one unifying factor which is to improve the lives of patients. We currently market a product for the treatment of acute attacks of hereditary angioedema (HAE), a rare genetic disease. We also have an...
We are seeking a Regulatory Affairs Associate to track the status and progress of regulatory documentation as well as review, edit and proofread regulatory documentation. Assist in preparation and review of labeling, SOPs, and other departmental documents. Compile under supervision regulatory documents for submission. Participate as an active team member of project teams as required. Compile and p...
Location: Cambridge, MA Job Category: Regulatory Affairs Jobs Requisition Number: 00470272-56561 Associate Vice President Regulatory Affairs-00470272-56561 Description Genzyme has pioneered the development and delivery of transformative therapies for patients affected by rare and debilitating diseases for over 30 years. We accomplish our goals through world-class research, collaboration with ...
Sanofi-Aventis Cambridge, MA
Description Genzyme has pioneered the development and delivery of transformative therapies for patients affected by rare and debilitating diseases for over 30 years. We accomplish our goals through world-class research, collaboration with the global patient community, and with the compassion and commitment of our employees. With a focus on rare diseases and multiple sclerosis, we are dedicated to...
Genzyme has pioneered the development and delivery of transformative therapies for patients affected by rare and debilitating diseases for over 30 years. We accomplish our goals through world-class research, collaboration with the global patient community, and with the compassion and commitment of our employees. With a focus on rare diseases and multiple sclerosis, we are dedicated to making a pos...
Central contact point for all Novartis Vaccines regulatory interactions with the respective local Health Authorities Monitors local guidelines and vaccine specific recommendations Prepares and/or comments on draft documentation sent out for consultation from the health authority Input to Regulatory Operations of local requirements fort he preparation of Clinical Trials Applications Gives local reg...
Kelly Services Cambridge, MA
A leading pharmaceutical company in the Cambridge, MA area has an immediate need for a Regulatory Affairs Associate Job Description: Report to head of submissions group, work with Regulatory Development managers on each program - Responsibilities include: - Act as liaison to CRO - Work with CRO to file initial CTAs clinical trial applications and amendments - Tracking of CTA filings and approval...
Location: Cambridge, MA Job Category: Regulatory Affairs Jobs Requisition Number: 70072044-38335 Associate Director Regulatory Affairs-70072044-38335 Description Genzyme has pioneered the development and delivery of transformative therapies for patients affected by rare and debilitating diseases for over 30 years. We accomplish our goals through world-class research, collaboration with the g...
PURPOSE AND SCOPE: Supports and assists Regulatory Affairs personnel with collection and preparation of documentation packages for medical device submissions to FDA. Assists with preparation of responses to regulatory agency questions. Organizes regulatory information resources. Tracks and controls regulatory submissions. Supports FMCNAâ??s mission, vision, core values and customer service philo...
Fresenius Medical Care Waltham, MA
PURPOSE AND SCOPE: Supports and assists Regulatory Affairs personnel with collection and preparation of documentation packages for medical device submissions to FDA. Assists with preparation of responses to regulatory agency questions. Organizes regulatory information resources. Tracks and controls regulatory submissions. Supports FMCNA’s mission, vision, core values and customer service philoso...

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