Manager Regulatory Affairs - Chicago

WeareseekingaRegulatoryAffairsSpecialisttosupportregulatarysubmissions,globalexceptions,labelingreviews,andcomplianceactivitiesforClassII/IIImedicaldevices.Bachelor'sorMaster'sinEngineering,Regulatory,Biomedical,LifesSciences3–7yearsofRegulatoryAffairsexperiencemedinmedicaldevice ...

The Regulatory Affairs Manager (CMC) position is responsible for authoring, review, preparation and management on-time filing of high-quality regulatory submissions with an emphasis on CMC. · The primary responsibility will include authoring, reviewing and preparing high quality ...

About this job: Regulatory Affairs Associate at Collabera in North Chicago, IL. · ...

As a Regulatory Affairs Specialist for Nature's Bakery you will be responsible for all aspects of ingredient on-boarding regulatory documentation regulatory compliance review and 3rd party certification submissions and managing approvals. · ...

Work on innovative combination products impacting patients globally. · ...

The Regulatory Affairs Associate will combine regulatory, business, and scientific knowledge to provide support with regulatory submissions, agency responses and internal queries for AbbVie global product portfolio. · ...

Develop global regulatory strategies for medical device products to meet business objectives and collaborates across a matrixed organization to ensure global success of products registration. · Negotiate with regulatory authorities to resolve questions/issues that arise during th ...

This role supports the company in regulatory issues and opportunities. It involves leading projects to ensure regulatory compliance and leveraging opportunities to benefit Conagra Brands. · ...

We are seeking a · Regulatory Affairs Specialist · to support regulatory submissions, · global registrations, · labeling reviews, · and compliance activities for Class II/III medical devices. · ...

As a Regulatory Affairs Specialist for Nature's Bakery, you will be responsible for all aspects of ingredient on-boarding, regulatory documentation, regulatory compliance review and third party certification (submissions and managing approvals). You may also play a role in produc ...

Responsible for technical writing of files in accordance with In Vitro Diagnostic medical device Regulation (IVDR) and provides regulatory support for diagnostic product development and commercial diagnostic products. · ...

We are seeking a Manager to play an integral role in ensuring that Capital One delivers on commitments to our regulators in a timely manner and proactively responds to the changing regulatory landscape. · ...

The Regulatory Affairs Manager (CMC) position is responsible for authoring, reviewing, preparing high quality regulatory submissions and managing post-approval maintenance of regulatory dossiers with an emphasis on CMC. · Authoring, reviewing and preparing high-quality ANDA, NDA, ...

+Work with a global leader in drug delivery and combination products delivering solutions that improve patient lives. · + · +Develop and execute CMC strategies for combination products · Assess PK/PD impact and support device bridging e.g.vial → autoinjector · ...

The Regulatory Affairs Manager (CMC) position is responsible for the author, review, preparation and manage on-time filing of high-quality regulatory submissions and for post-approval maintenance of regulatory dossiers with an emphasis on CMC. · * Assimilate to changing environme ...

+The Regulatory Affairs Manager (CMC) position is responsible for the author review preparation and manage on-time filing of high-quality regulatory submissions and for post-approval maintenance of regulatory dossiers with an emphasis on CMC. · +* Authoring reviewing and preparin ...

The Director of Regulatory Affairs will lead all of Prolaio's regulatory efforts. · This role is responsible for building and executing the regulatory strategy that ensures our products are cleared and we are compliant. · This individual will work closely with the FDA and other a ...

The Vice President of Regulatory Affairs will serve as the senior-most regulatory leader responsible for envisioning, developing, and executing the company's global regulatory strategy to support clinical development, product approvals, lifecycle management, and ongoing complianc ...

The Regulatory Affairs Specialist III position involves global product registrations ensuring regulatory compliance in medical devices design manufacturing sales including Class I II devices software as a medical device de novo devices. · ...

This job is with Johnson & Johnson in Mexico City. The Regulatory Affairs Head will manage the coordination and submission of new drug applications to regulatory agencies. ...