Preferred Experience: Experience in Regulatory Affairs preferred but may consider QA, R&D/support, Scientific affairs, operations, or related area Experience in Regulatory Operations, including regulatory submission project management and/or submission publishing is preferred. The Senior Associa...
Preferred Experience: Experience in Regulatory Affairs preferred but may consider QA, R&D/support, Scientific affairs, operations, or related area Experience in Regulatory Operations, including regulatory submission project management and/or submission publishing is preferred. The Senior Associa...
The Associate, Regulatory Affairs Submission Management, manages low to medium impact submission projects involving multiple cross-functional regulatory submission teams. With input from the submission teams, this individual establishes and maintains submission content planners and associated timeli...
In addition, Senior Regulatory Affairs Associate is responsible for supporting a variety of activities in the department related to regulatory submissions and R&D requests, and supporting other departments within the organization. Ability to review regulatory and scientific submission documents for ...
Duration: 1 yearEmployment Type: W-2 Overview:The Associate, Regulatory Affairs Submission Management, manages low to medium impact submission projects involving multiple cross-functional regulatory submission teams. With input from the submission teams, this individual establishes and maintains su...
These elements include FDA, EPA, OSHA, ISO, EEOC and Company policies relative to the manufacture of product, lot control requirements, documentation requirements, housekeeping, preventative maintenance, calibration, associate training and safety (equipment, associate and material). Ensures departme...
Are you a compassionate leader eager to steer and elevate a crucial healthcare program? Join Encompass Health, the nation's largest inpatient rehabilitation company, as a Dialysis Program Manager. Dialysis Program Manager Career Opportunity. Recognized for your expertise as a Dialysis Program Manage...
Technical Project Manager Responsibilities. Our diverse range of projects employs qualitative methodologies to delve into community contexts, fostering dialogues that lead to consensus on crucial intervention planning matters. Develop and update code and scripts for R Shiny apps to assess and addres...
The Associate Specialist, US Commercial Compliance, OPENDOOR team assists customer-facing personnel in overcoming credentialing challenges to obtain and maintain compliant access to their customers. ...
The Specialist, Compliance Operations is responsible for being a key contributor to the US Commercial Compliance Operations program for over 9000 US Commercial learners. Specialist, Compliance Operations. This role will perform assessments in partnership with the Compliance Training and AbbVie Learn...
The Associate Director, Regulatory Strategic Planning is responsible for successfully delivering project management capabilities for highly complex, cross-functional teams within and across the Regulatory Affairs organization. The individual combines knowledge of scientific, regulatory, and business...
Responsible for a product(s) or products with multiple driver indications within a Therapeutic Area and supports the Manager (Global Regulatory Lead (GRL), Associate Director, or Director), in the development & execution of the regulatory strategy. Assures that regulatory strategies defined with...
Represents CMC regulatory affairs on teams such as the product development, Global Regulatory Product Teams and Operations brand teams, for assigned projects; negotiates with and influences team members with support of management to maximize chances for first pass approval of regulatory submissions....
The Program Manager, Clinical Supply Chain Managements primary responsibility is to manage the clinical supply chain for early phase (uncomplicated) compounds. Define and implement a global clinical supply strategy, in conjunction with mentor or experienced Drug Supply Manager. Matrix management of ...
The Senior Manager, RA In Vitro Diagnostics and Companion Diagnostics, works with internal and external partners to deliver products to patients. Support the development of the device regulatory strategy and provide device input into the preparation and maintenance of chemistry, manufacturing, and c...
The Program Manager/Senior Program Manager, CMC Portfolio Management will provide end-to-end strategic portfolio leadership with a focus on proactive identification of acceleration opportunities and/or roadblocks to enable cross-functional teams to achieve key asset milestones. Program Manager will ...
Director, Safety, Regulatory and Medical Affairs Quality Standards is responsible for the management of a RDQA global Safety, Regulatory Affairs (RA) and Medical Affairs (MA) QA team which provides independent quality oversight of GxP activities, covering the AbbVie drug, device and cosmetic portfol...
Responsible for a product(s) or products with multiple driver indications within a Therapeutic Area and supports the Manager (Global Regulatory Lead (GRL), Associate Director, or Director), in the development & execution of the regulatory strategy. Assures that regulatory strategies defined with...
Project Manager – Commercial Electrical Contractor. Project managers report to office and have flexibility to manage work/life issues that come up on occasion. You will have a critical role in developing customers, identifying & estimating projects, and managing a variety of high-profile, ...
Manager, Regulatory Affairs - Labeling. Independently ensuring all project timelines and regulatory commitments are met for labeling at all stages of the product lifecycle, and with no disruptions to commercial availability of marketed products, driving measurable efficiencies and continuous improve...
The Director Regulatory Affairs, Strategic Labeling is responsible for setting strategy and leading cross-functional, multidisciplinary, therapeutic teams, and executing multidivisional initiatives for labeling activities for drugs, devices and combination products in assigned therapeutic area(s). E...
The Associate Director, Regulatory Strategic Planning is responsible for successfully delivering project management capabilities for highly complex, cross-functional teams within and across the Regulatory Affairs organization. The individual combines knowledge of scientific, regulatory, and business...
Senior Regulatory Affairs Specialist. Senior Regulatory Affairs Specialist. Bachelors degree in regulatory affairs preferred and may be used in lieu of direct regulatory experience, or an equivalent combination of education and work experience. Participate as the regulatory functional product team m...
The Project Manager acts as a lead for SKMM projects and manages the schedule for timely completion of the assigned projects. The Project Manager will interact and present to various customer and internal groups regarding ongoing projects, participating in the establishment, design, and implementati...
Represents CMC regulatory affairs on teams such as the product development, Global Regulatory Product Teams and Operations brand teams, for assigned projects; negotiates with and influences team members with support of management to maximize chances for first pass approval of regulatory submissions....