or global process improvements for activities relating to the work of RA Ad/Promo. Provides regulatory guidance on new... of regulatory affairs is a plus. Experience authoring and/or implementing processes. Experience successfully leading...
, 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 to R...
. This position will be based in Mounds View, MN or Santa Rosa, CA. The Senior Regulatory Affairs Specialist will support Research... and Development programs with pre-market regulatory strategy development for worldwide product registration with global regulatory...
. This position will be based in Mounds View, MN or Santa Rosa, CA. The Senior Regulatory Affairs Specialist will support Research... and Development programs with pre-market regulatory strategy development for worldwide product registration with global regulatory...
Regulatory and Medical/Clinical Affairs teams. This individual will provide financial support for the R&D Team for Plan, RLBEs...Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life...
goal outcome and how we achieve it. Purpose This position reports directly to the Manager of Rates and Regulatory... Affairs and provides complex analytical work in support of regulatory proceedings and decisions. The position will be involved...
. Finally, you will cooperate with Regulatory Authorities, through country, regional and Global networks, thereby shaping the... those for existing ones according to business objectives. The primary responsibilities of this role, Regulatory Affair Manager...
Responsibilities: The Associate Regulatory Affairs Manager will support the development, review, and submission... compliance with FDA, ISO 13485, and other global regulatory requirements. The Associate Manager will work cross-functionally...
with a true leader in the global energy transformation. Under limited supervision, the Manager, Regulatory Affairs... before the Indiana Regulatory Commission, provides financial, technical, and regulatory analysis supporting senior management...
Responsibilities: The Associate Regulatory Affairs Manager will support the development, review, and submission... compliance with FDA, ISO 13485, and other global regulatory requirements. The Associate Manager will work cross-functionally...
clinic using our innovative manufacturing approach to cell and gene therapies. As the Senior Manager Regulatory Affairs..., you will be a key member of a small, dynamic, and fast-paced Regulatory team who will support the Associate Director, Regulatory Affairs...
Currently seeking a Regulatory Affairs (RA) Senior Manager with strong CMC pre and post approval experience to support Chiesi...(s) In alignment with GRDRA CMC functions, GRDRA region functions and Senior Director or Reg CMC Lead, agree on the regulatory strategy...
experience required for the Senior Manager Regulatory level. Candidates must have regulatory affairs experience working... with regulatory standards Serve as representative of Global Regulatory Affairs at project team meetings with both external...
to improve hospital efficiency and enhance patient care. Overview: Role Summary: The Regulatory Affairs Manager II leads the... Support the Senior Manager as needed. Skills & Capabilities: Regulatory & Analytical Rigor: Interprets complex regulations...
Responsibilities: The Associate Regulatory Affairs Manager will support the development, review, and submission... compliance with FDA, ISO 13485, and other global regulatory requirements. The Associate Manager will work cross-functionally...
experience required for the Senior Manager Regulatory level. Candidates must have regulatory affairs experience working... with regulatory standards Serve as representative of Global Regulatory Affairs at project team meetings with both external...
experience required for the Senior Manager Regulatory level. Candidates must have regulatory affairs experience working... with regulatory standards Serve as representative of Global Regulatory Affairs at project team meetings with both external...
. Responsibilities: The Regulatory Affairs Manager will report to the Senior Director of Global Regulatory Affairs (located in the EU... of manager. Participates in internal initiatives to Veracyte Global Regulatory Affairs. Develops and assists in implementing...
The Senior Principal, Regulatory Affairs will provide oversight and lead global submission work including in support... reports to the Director, Regulatory Affairs and is part of the Global Regulatory Affairs and will be fully remote Lead...
Responsibilities: Support the Senior Director in developing and executing regional regulatory strategies for QOL... to the Senior Director and Associate Director. Contribute to managing regulatory risks and opportunities related to QOL...