Regulatory Affairs Associate Jobs in Massachusetts

326 jobs

Microline Surgical develops and manufactures high precision open and laparoscopic surgical instruments. Microline’s laparoscopic reposable instruments provide a cost-effective, eco-friendly solution for today’s OR. The MiFusion product line offers a broad spectrum of open and laparoscopic instruments used to seal and divide tissue utilizing proprietary thermal fusion technology. JOB SUMMARY: Und...

Microline Surgical develops and manufactures high precision open and laparoscopic surgical instruments. Microline’s laparoscopic reposable instruments provide a cost-effective, eco-friendly solution for today’s OR. The MiFusion product line offers a broad spectrum of open and laparoscopic instruments used to seal and divide tissue utilizing proprietary thermal fusion technology. JOB SUMMARY: Wor...

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 the global patient community, and with the compassion and commitment of our employees. With a focus ...

Regulatory Affairs and Compliance Manager Position Purpose: Provides Regulatory Affairs oversight and compliance support for commercially manufactured APIs and during clinical product development. Functions as the Regulatory Affairs and Compliance resource and is expected to monitor global regulatory agency publications, proposed guidances, inspection reports, and expectations to determine trend...

Kelly Clinical Research has an exciting opportunity for a Post-Market Senior Regulatory Affairs Specialist. This is a contract role in Mansfield, MA at a leading medical device company. SUMMARY OF POSITION: Primary responsibility is for leading and managing the post-market field activities of medical device products and processes and to coordinate across the global business the customer notifica...

AD Regulatory Affairs-00471128-60347JC 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...

This position is responsible for providing support for regulatory execution activities associated with investigational and marketed products. The role involves coordinating, writing, and reviewing documents for regulatory submission purposes, with an emphasis on clinical trial applications; conducting regulatory research; summarizing information for the team; and helping to share, rapidly dissemin...

Company Confidential
Executive Director Regulatory Affairs My client is a small, rapidly growing pharmaceutical company focused in the treatment for various metabolic diseases. They are developing new methods for patients world-wide and are in search of an Executive Director to lead their NDA program to file with FDA and global agencies. You will be covering both regulatory development strategies as well as program m...

*Org Marketing Statement*All over the world, Pfizer colleagues are working together to positively impact health for everyone, everywhere. Each position at Pfizer touches and contributes to the success of our business and our world. That’s why, as one of the global leaders in the biopharmaceutical industry, Pfizer is committed to seeking out inspired new talent who share our core values and mission...

Alkermes plc is a fully integrated, global biopharmaceutical company developing innovative medicines for the treatment of central nervous system (CNS) diseases. The company has a diversified commercial product portfolio and a substantial clinical pipeline of product candidates for chronic diseases that include schizophrenia, depression, addiction and multiple sclerosis. Headquartered in Dublin, Ir...

•Responsible for directing global regulatory strategies for assigned projects and programs. •Identify and assess regulatory risks associated with product development. Define strategies to mitigate risks. •Provide regulatory guidance to company personnel throughout the research and development process. •Direct the organization and preparation of clear and effective submissions. •Prepare and del...

Amgen is a leading human therapeutics company in the biotechnology industry. For more than 35 years, the company has tapped the power of scientific discovery and innovation to advance the practice of medicine. As a Fortune 500 company serving millions of patients, Amgen continues to be an entrepreneurial, science-driven enterprise dedicated to helping people fight serious illness. • Support RA CM...

PURPOSE AND SCOPE: Supports FMCNA???s mission, vision, core values and customer service philosophy.Adheres to the FMCNA Compliance Program, including following all regulatory and division/company policy requirements. Responsible for supporting the daily operational activities within Regulatory Affairs for the preparation of regulatory submissions required to market new or existing licensed pharm...

•Responsible for directing global regulatory strategies for assigned projects and programs. •Identify and assess regulatory risks associated with product development. Define strategies to mitigate risks. •Provide regulatory guidance to company personnel throughout the research and development process. •Direct the organization and preparation of clear and effective submissions. •Prepare and del...

Overview Senior Associate, Regulatory Affairs in Cambridge, MAARIAD Branch CambridgeMAUS Position:Senior Associate, Regulatory AffairsLocation:Cambridge, MA Support the preparation, review, and approval of compliant regulatory documents throughout the product lifecycle…. Supports regulatory objectives, strategy and filing activities in alignment with department and corporate goals. Plays acti...

Alkermes plc is a fully integrated, global biopharmaceutical company developing innovative medicines for the treatment of central nervous system (CNS) diseases. The company has a diversified commercial product portfolio and a substantial clinical pipeline of product candidates for chronic diseases that include schizophrenia, depression, addiction and multiple sclerosis. Headquartered in Dublin, Ir...

Job Summary: Responsible for the implementation and administration of organization activities to support and ensure regulatory compliance. Reports to Regulatory Affairs Manager. Essential Functions: Prepare 510(k) and International product submissions Support International product registrations Prepare and maintain product Technical Files Manage organization's external document control Assi...

Location: Cambridge, MA Job Category: Regulatory Affairs Jobs Requisition Number: 00470272-56561 Associate Vice President Regulatory Affairs-00470272-56561DescriptionGenzyme 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 ...

PURPOSE AND SCOPE: Supports FMCNA???s mission, vision, core values and customer service philosophy.Adheres to the FMCNA Compliance Program, including following all regulatory and division/company policy requirements. To ensure overall (other than auditing responsibilities) regulatory approval and post-marketing compliance for FMCNA drug product, this position will: Supervise and guide assigned ...

Sr. Associate II, Regulatory Affairs Level - Responsible for submission activity on several programs if appropriate - Report to Associate Director or above to work on programs - Responsibilities include: - Act as liaison to Regulatory Affairs, as appropriate - Attend SMT meetings for relevant clinical studies - Liaise with Regulatory Affairs colleagues on filings/amendments as appropriate Lo...