Associate Director, Global CMC Regulatory Affairs - Chicago, Illinois, United States

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

Prolaio is creating smarter ways to address heart disease and heart risks by integrating a connected platform enabled by smart data science to help patients access the care and attention that will inform better treatments and outcomes. · ...

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. · ...

· Full-time · Description · About Us: · Founded in 2017 and based in Chicago, Meitheal is focused on the development and commercialization of generic injectable medications and, as of 2022, has expanded its focus to include fertility, biologic, and branded products. Meitheal cur ...

· Who Are We? · Prolaio believes that continuous learning and collaboration can make a significant difference in how heart care is administered. We are creating smarter ways to address heart disease and heart risks by integrating a connected platform enabled by smart data scienc ...

· Company Description · About Collabera: · Established in 1991, Collabera is one of the fastest growing end-to-end information technology services and solutions companies globally. As a half a billion dollar IT company, Collabera's client-centric business model, commitment to se ...

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. · ...

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

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. · ...

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 ...

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 ...

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. · ...

Reporting to the Senior Director Regulatory Affairs you will support the company in regulatory issues and opportunities. · In this position you will help lead projects programs and/or processes to ensure regulatory compliance and to leverage regulatory opportunities to the benefi ...

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, ...

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 ...

+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. · +* 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 ...

דף הבית » משרות » Regulatory Affairs Specialist · Regulatory Affairs Specialist · מיקום: · יקנעם · אופן העסקה: · היברידי · תיאור התפקיד: · תפקיד הכולל אחריות על ניהול והובלת תהליכים רגולטוריים גלובליים, כולל הכנת מסמכים, הגשות לרשויות, ותמיכה בעמידה בדרישות התקינה והמדיניות הבינל ...

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 ...