Senior Regulatory Affairs Specialist. Senior Regulatory Affairs Specialist. Participate as the regulatory functional product team member for the organization’s Transfusion Medicine regulatory team. Assist in the development of regional regulatory strategy and update strategy based upon regulatory ch...
Prepares robust regulatory applications (either for FDA or for international regulatory agencies) to achieve departmental and organizational objectives. Acts as core team member providing review and analysis of applicable regulatory guidelines and project regulatory assessments as needed. Reviews an...
Review and process entry of HMDA and CRA reportable loans with 100% accuracy into Compliance CRA Wiz system following current regulatory guidelines. Then preparing a HMDA or CRA packet for all identified loans for regulatory purposes. ...
Handling data management and retrieval of regulatory documents. Preparing and submitting US regulatory filings on time and in compliance. Staying current with regulations and providing expertise in regulatory affairs. Training team members and ensuring regulatory compliance. ...
Which includes: tracking of status and progress of regulatory documentation, reviewing, editing and proofreading regulatory documentation, participating as an active team member of project teams as required, maintaining regulatory files in a format consistent with requirements as well as staying awa...
The International Regulatory Specialist is responsible for providing regulatory support to Rust-Oleum’s international business. Be part of a regulatory team that supports a >. ...
Senior Regulatory Affairs Specialist. Participate as the regulatory functional product team member for the organization’s Transfusion Medicine regulatory team. Assist in the development of regional regulatory strategy and update strategy based upon regulatory changes. Understand, investigate, and ev...
Senior Regulatory Affairs Specialist. Understand and apply regulatory requirements, and prepare and submit regulatory documents. Stay informed about regulatory guidelines, policies, and standards. Know the structure and processes of regulatory agencies. ...
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...
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 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...
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 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...
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...
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...
The Associate Project Manager will serve both as the lead project manager and assist with multiple projects in R&D, including both Product Development and Design Change projects, to ensure their compliance to design processes within defined timeframes and resource allocation. We are seeking an A...
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 Senior Manager, Customer Experience Programs oversees the voice of the customer programs that drive engagement, satisfaction, loyalty, retention, and advocacy within Encore's customer base. This includes overseeing the design, implementation, and maintenance of VOC program tools (Medallia), anal...
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...
The Sr Program Manager will support programs of small to medium scope, or a significant subsection of a large program. The Patient Support Services (PSS) Program Management (Primary Care Business Unit) Sr Program Manager will be part of the US Market Access Patient Support Services at Pfizer Digital...
Support the development of the device regulatory strategy and provide device input into the preparation and maintenance of chemistry, manufacturing, and controls (CMC) device sections of regulatory submissions, responses to Agency questions for worldwide registration and lifecycle management for the...