Associate Director, CMC Regulatory Affairs - Danbury, CT - Mannkind Corporation

The Director of Regulatory Affairs will lead global regulatory strategies for chemical products within the consumer packaged goods (CPG) sector. · Develop and implement global regulatory strategies for chemical products in the CPG sector. · Lead risk assessments to evaluate regul ...

Regulatory Manager – Point-of-Care Diagnostics. The company is a fast-growing medical diagnostics startup developing point-of-care technology that provides rapid insight into a patient's coagulation status. · Lead and support regulatory activities with strong focus on EU CE/IVDR ...

This is a HYBRID role and you must be able to work from one of our office locations. This role requires travel to different locations domestic and international. The Director of Regulatory Affairs will lead global regulatory strategies for chemical products within the consumer pa ...

Regulatory Manager – Point-of-Care Diagnostics in Connecticut (Hybrid) | Full-time. Partnered with a fast-growing medical diagnostics startup developing point-of-care technology that provides rapid insight into a patient's coagulation status. · Lead and support regulatory activit ...

Regulatory Manager – Point-of-Care Diagnostics. Hands-on Regulatory Manager to drive EU regulatory strategy and submissions as they scale. · Lead and support regulatory activities with strong focus on EU CE/IVDR submissions. · Prepare, coordinate, and maintain technical documenta ...

Regulatory Manager – Point-of-Care Diagnostics. Shape regulatory strategy in a scaling, high-impact environment. Work on technology with meaningful clinical application in emergency and critical care. Highly cross-functional role with broad ownership and visibility. · ...

MannKind Corporation has an opening for a Associate Director, CMC Regulatory Affairs in Danbury, CT. · Lead and compile global regulatory submissions using eCTD. · Oversee the preparation of responses to deficiency comments/letters from health authorities and provide input and gu ...

MannKind Corporation has an opening for a Associate Director, CMC Regulatory Affairs in Danbury, CT · Lead and compile global regulatory submissions using eCTD · Oversee the preparation of responses to deficiency comments/letters from health authorities · Assist with development ...

Lead and compile global regulatory submissions using eCTD. Oversee the preparation of responses to deficiency comments/letters from health authorities and provide input and guidance on interpretation of deficiency comments and guide the formulation of responses. · Lead and compil ...

MannKind Corporation has an opening for a Associate Director, CMC Regulatory Affairs in Danbury, CT. The Associate Director will lead and compile global regulatory submissions using eCTD, oversee the preparation of responses to deficiency comments/letters from health authorities, ...

Lead and compile global regulatory submissions using eCTD. Oversee the preparation of responses to deficiency comments/letters from health authorities and provide input and guidance on interpretation of deficiency comments and guide the formulation of responses. · Assist with dev ...

MannKind Corporation has an opening for a Associate Director, CMC Regulatory Affairs in Danbury, CT. The Associate Director will lead and compile global regulatory submissions using eCTD, oversee the preparation of responses to deficiency comments/letters from health authorities, ...

The Regulatory Affairs Fellow will obtain broad exposure to BI US Medical functions, including Medical Affairs and Scientific Communications, clinical operations, translational medicine and clinical pharmacology, and regulatory affairs. · Review and approval of promotional commun ...

The Clinical Development and Medical Affairs Fellow is a post-doctoral pharmacist position that will obtain broad exposure to BI US Medical functions including, but not limited to Medical Affairs and Scientific Communications, clinical operations, translational medicine and clini ...

Regeneron is seeking a Manager, of Advertising and Promotion to join our Regulatory Affairs team. Provides regulatory advertising and promotion expertise to relevant stakeholders. · Manages commercial activities from a regulatory advertising and promotion perspective. · Collabora ...

Celldex is a clinical-stage biotechnology company dedicated to developing novel antibody-based treatments that improve the lives of patients with allergic, inflammatory and autoimmune disorders. As our pipeline progresses toward major regulatory milestones, we are seeking a highl ...

Regeneron is seeking a Manager, of Advertising and Promotion to join our Regulatory Affairs team. In this role, you will apply clinical development knowledge in concert with experienced understanding of advertising and promotion regulations/guidances to the development of key pro ...

Contemporary Staffing Solutions is seeking a Regulatory Affairs Specialist to join our client to support regulatory compliance initiatives and ensure accurate documentation across multiple product lines. · Conduct research on federal, state, and international regulations, summari ...

We are driven by our Mission to alleviate pain, restore health, and extend life for patients around the world. As a Regulatory Affairs Specialist, you will play a vital role in supporting ongoing product compliance by assessing changes to existing medical devices and ensuring all ...

As a Regulatory Affairs Coordinator, you will be responsible for maintaining all aspects of continued certification for the BRC and ISO quality schemes including reviewing and updating current documentation. · Lead Regulatory/Quality functions. · Maintain certifications for ISO, ...

As a Regulatory Affairs Coordinator, you will be responsible for maintaining all aspects of continued certification for the BRC and ISO quality schemes including reviewing and updating current documentation. Additional duties will include managing compliance with governmental reg ...