PURPOSE AND SCOPE: Leads regulatory surveys and promotes utilization of continuous quality improvement (CQI... with Quality, Education and Operational management to ensure the continual improvement of regulatory compliance by company...
(k), PMA, and PMA supplement submissions. Deep knowledge of regulatory strategy creation, design control, cGMP/Quality Systems...Responsibilities: Responsible for providing guidance to ensure that all regulatory submissions are planned...
regulatory submissions. Support all Company initiatives as identified by management and in support of Quality Management Systems... experience. Must be familiar with relevant US/international regulatory requirements for medical devices including Quality...
, and annual reports. Documentation: Draft and maintain high-quality CMC regulatory documents such as Module 2 and 3 summaries...Responsibilities: Author and compile CMC sections of regulatory applications, including INDs, IMPDs, CTAs, amendments...
Responsibilities: Support the Senior Director in developing and executing regional regulatory strategies for QOL.... initiatives within specific regions. Contribute to providing strategic oversight and leadership to the regulatory team, ensuring...
Responsibilities: Maintain full awareness of all regulatory activities on assigned Project(s) and ensure that the... stakeholders to manage submission schedules. Compile high quality and right first-time submissions (Abbreviated New Drug...
, submission, and monitoring of PLAIR activities, prior to new product launch. Manage regulatory correspondence mainly to CDER..., FDA, User fee staff, drug listing and Board of Pharmacies for state licensing submissions. Provide regulatory guidance...
Responsibilities: The delivery of regulatory guidance to project teams and external partners is a key activity... that assists the company in achieving its business goals. The incumbent will serve as a member of the Global Regulatory department...
-quality and timely deliverables Develop and maintain best practices for regulatory compliance Assist in the coordination... Institutions have drastically changed over the last decade, driven by increased regulatory constraints, diverse competition inside...
regulatory outcomes. Collaborate with internal stakeholders, including Manufacturing, Quality Assurance, Quality Control, Supply... on quality, accuracy, and compliance. Experience with regulatory submissions for small molecules, biologics...
-quality and timely deliverables Develop and maintain best practices for regulatory compliance Assist in the coordination... Institutions have drastically changed over the last decade, driven by increased regulatory constraints, diverse competition inside...
on with their lives. This position provides regulatory compliance leadership for the business, ensuring the policies, procedures..., and practices of the business remain compliant to regulatory and contract requirements. What You’ll Work On Directly manages team...
devices under a strong portfolio of world class brands. Dentsply Sirona's products provide innovative, high-quality... Solutions team. This role develops regulatory strategies for existing, new, and modified medical devices and other (regulated...
Job description: Grounded in safety, quality, and ethics, our experts lead their fields with dedication, a creative... and constraints within the changing regulatory and corporate environment, through active engagement with the public, stakeholder...
Job description: Grounded in safety, quality, and ethics, our experts lead their fields with dedication, a creative... and constraints within the changing regulatory and corporate environment, through active engagement with the public, stakeholder...
Job description: Grounded in safety, quality, and ethics, our experts lead their fields with dedication, a creative... and constraints within the changing regulatory and corporate environment, through active engagement with the public, stakeholder...
Job description: Grounded in safety, quality, and ethics, our experts lead their fields with dedication, a creative... and constraints within the changing regulatory and corporate environment, through active engagement with the public, stakeholder...
Job description: Grounded in safety, quality, and ethics, our experts lead their fields with dedication, a creative... and constraints within the changing regulatory and corporate environment, through active engagement with the public, stakeholder...
Job description: Grounded in safety, quality, and ethics, our experts lead their fields with dedication, a creative... and constraints within the changing regulatory and corporate environment, through active engagement with the public, stakeholder...
Job description: Grounded in safety, quality, and ethics, our experts lead their fields with dedication, a creative... and constraints within the changing regulatory and corporate environment, through active engagement with the public, stakeholder...