The Senior Associate, Regulatory Affairs Submission Management, manages medium to high impact, moderately complex submission projects involving multiple cross-functional regulatory submission teams. Preferred Experience: Experience in Regulatory Affairs preferred but may consider QA, R&D/support...
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...
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...
The Senior Associate, Regulatory Affairs Submission Management, manages medium to high impact, moderately complex submission projects involving multiple cross-functional regulatory submission teams. Preferred Experience: Experience in Regulatory Affairs preferred but may consider QA, R&D/support...
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...
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...
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 ...
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...
Responsible for filing necessary applications and handling all government interactions pertaining to the regulation process for products requiring governmental approval.Authoring and submitting PMA supplements (-day Notice, Real-Time Reviews, -Day Supplements, Annual Reports).Review/approval of engi...
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 Associate, Global Regulatory Operations. Global Regulatory Affairs Department. Responsibilities also include archiving regulatory submissions in accordance with company standards. Performs moderately complex to non-routine submission publishing activities associated with generating electronic...
The Executive Assistant provides support to the Executive team in making travel arrangements, preparing expense reports, scheduling meetings, and handling other administrative tasks including managing calendars, developing presentation slides, and drafting correspondence.The Executive Assistant must...
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...
Associate Regulatory Operations Manager in Northbrook, IL to prepare, submit, distribute, and archive routine regulatory agency submissions. ...
The Compliance Specialist will coordinate research compliance activities at the University's lakeside campuses to ensure regulatory compliance in human subjects research and animal research. Compliance with the regulations requires administrative support of the chairperson of the Institutional Revie...
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 Senior, US Therapeutics Financial Compliance assists with the execution of the US Therapeutics & Aesthetics Financial Compliance program for Federal ‘Sunshine’ Reporting. Meets deadlines to ensure all areas of responsibility are timely and accurate in reporting of data ensuring a...
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...
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....
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...
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 Manager of Regulatory Affairs – Product Development and Post Approval serves as the primary regulatory interface with Partners and internal teams regarding Drug Product and Analytical method development and post-approval activities. Manager, Regulatory Affairs – Product Development a...
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...
The Senior Manager, Global Regulatory Affairs Strategy (US & Canada) is responsible for the following:. Supporting teams & efforts around major filing activities & Regulatory Health Authority (RHA) interactions & meetings, attending & providing regulatory support to other departm...
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....