Drive best practices and operational excellence within the department and cross-functionally by providing key regulatory intelligence updates via knowledge sharing and training to advance US regulator...

Drive best practices and operational excellence within the department and cross-functionally by providing key regulatory intelligence updates via knowledge sharing and training to advance US regulator...

The Senior Specialist Regulatory Affairs executes on the pharmaceutical regulatory strategies for assigned brand products. Strong business acumen and ability to see the business drivers outside of Reg...

The Senior Regulatory Affairs Specialist will support the International Regulatory team in preparing regulatory submissions for our Butterfly Ultrasound Systems and help coordinate, track, and communi...

Ensure compliance with internal procedures as the Regulatory Affairs point of contact for onboarding activities and global contact for training and reporting. Manages regulatory projects within the re...

The Senior Specialist Regulatory Affairs executes on the pharmaceutical regulatory strategies for assigned brand products. Liaise with country-specific regulatory affairs personnel for international s...

The Senior Regulatory Affairs Specialist will support the International Regulatory team in preparing regulatory submissions for our Butterfly Ultrasound Systems and help coordinate, track, and communi...

Drive best practices and operational excellence within the department and cross-functionally by providing key regulatory intelligence updates via knowledge sharing and training to advance US regulator...

Support regulatory impact assessments for change controls and other Regulatory Affairs/Quality Assurance items from a review and approval level. As a Staff Regulatory Affairs Specialist in Advertising...

As a Staff Regulatory Affairs Specialist in Advertising/Labeling, you will play a crucial role in supporting Medication Management Solutions (MMS) Dispensing products, including Medical Devices, Non-M...

About CooperSurgical CooperSurgical is a leading fertility and women's healthcare company dedicated to putting time on the side of women, babies, and families at the healthcare moments that matte...

About CooperSurgical CooperSurgical is a leading fertility and women's healthcare company dedicated to putting time on the side of women, babies, and families at the healthcare moments that matte...

This position will manage all regulatory affairs activities for Laundry and Dish categories in the US. This includes labeling, product development compliance, package development, SDS and ingredients ...

The Regulatory Affairs Specialist will review and approve Dietary Supplement/Food labels for technical accuracy and compliance to all mandated regulatory requirements, provide information to rectify l...

The Regulatory Affairs Specialist will review and approve Dietary Supplement/Food labels for technical accuracy and compliance to all mandated regulatory requirements, provide information to rectify l...

This position will manage all regulatory affairs activities for Laundry and Dish categories in the US. This includes labeling, product development compliance, package development, SDS and ingredients ...

The Regulatory Affairs Specialist coordinates, facilitates, and reports on post-market regulatory programs. Implements regulatory activities such as obtaining global regulatory clearances and/or appro...

Contribute to continuous improvement initiatives within the regulatory affairs function. Provide consultation and advice to regulatory specialists regarding change control and product development. Off...

Performs quality control, research source documentation verification against case report form data, including informing the site staff of any entry errors, ensuring that Good Clinical Practices (GCP) ...

Certification is a plus (such as RAC from the Regulatory Affairs Professionals Society. Anticipate regulatory obstacles and emerging issues throughout the product submission. Provide regulatory input ...

Certification is a plus (such as RAC from the Regulatory Affairs Professionals Society. Ensure external communications for regulatory purposes meet regulations. Practical experience in leading cross-f...

Regulatory Affairs or equivalent industry experience is required. Knowledge in relevant Regulatory Affairs areas. Maintains advanced and current knowledge of relevant regulations, policies, and guidel...

This position is responsible for the preparation of regulatory submissions required to market medical devices in both the and Europe, support of international product registrations and related regulat...

This position is responsible for the preparation of regulatory submissions required to market medical devices in both the and Europe, support of international product registrations and related regulat...

Eligibilities & qualifications.

Eligibilities & qualifications.

Working knowledge of relevant federal and state regulatory programs (e.

Working knowledge of relevant federal and state regulatory programs (e.

Prepare new/revised label packaging for regulatory submissions to the USDA and maintain regulatory documents to ensure site compliance. Support regulatory filing submissions with the USDA for both dom...

Prepare new/revised label packaging for regulatory submissions to the USDA and maintain regulatory documents to ensure site compliance. Support regulatory filing submissions with the USDA for both dom...

Regulatory Affairs Specialist Project Lead I (Scientific). This role will be accountable for leading the development and execution of innovative and value-added global regulatory strategies and be res...

Regulatory Affairs Specialist Project Lead I (Scientific). This role will be accountable for leading the development and execution of innovative and value-added global regulatory strategies and be res...

Regulatory Affairs Documentation Specialist. A Regulatory Affairs Documentation Specialist utilizes strong written communication skills to enhance the level of documentation maintained within the Depa...

Provide guidance to the company and subsidiaries to perform actions in order to maintain regulatory compliance for various facilities. Develop appropriate awareness and training programs for TSMs cons...

Support Distribution Center management and designated staff on the actions necessary to maintain regulatory compliance. Provide guidance to the company and subsidiaries to perform actions in order to ...

At least 8-10 years of relevant pharmaceutical/biotechnology experience in R&D, including at least 5 years of relevant Regulatory Affairs experience (regionally and/or global), in early development. T...

At least 8-10 years of relevant pharmaceutical/biotechnology experience in R&D, including at least 5 years of relevant Regulatory Affairs experience (regionally and/or global), in early development. T...

Regulatory expert support IVDR teams, implements regulatory strategies for IVDR activities; provides regulatory leadership; collaborates with the regulatory staff from other business units, companies,...

Reviews and assesses proposals to regulatory authorities on regulatory paths and clinical plans. They engage in correspondence, meetings, and interactions with the FDA to address regulatory inquiries,...

They engage in correspondence, meetings, and interactions with the FDA to address regulatory inquiries, respond to requests for additional information, and seek clarification on regulatory matters und...