- Pall (Miami, FL)
- …for compliance with regulations and statutes. Determine the need for and prepare regulatory submissions , negotiate the resolution of agency questions, and secure ... Business System which makes everything possible.Director Global Quality and Regulatory ComplianceJOB SUMMARYInterprets federal/state/international regulations as they apply to… more
- Cardinal Health (Columbus, OH)
- **_What Regulatory Submissions Operations contributes to Cardinal Health_** Regulatory Submissions Operations provides regulatory affairs and product ... to provide services in technical writing, scientific data verification, and basic regulatory submissions within the discipline of chemistry, manufacturing, and… more
- J&J Family of Companies (Raritan, NJ)
- …needed, and coordinate with dossier level publishing partners to achieve production of regulatory submissions that conform to regional and country specific ... **Job Function:** Regulatory Affairs Group **Job Sub** **Function:** Regulatory Product Submissions and Registration **Job Category:** Professional **All… more
- Medtronic (Los Angeles, CA)
- …on meeting business objectives with excellence. From developing and authoring regulatory submissions to providing critical input on cross-functional project ... and modified Class IIa & Class III devices and preparing and submitting regulatory submissions in the EU and supporting outside of US (OUS) geographies. +… more
- Grifols Shared Services North America, Inc (Clayton, NC)
- …products. + Prepare responses to regulatory agency inquiries. + Compile regulatory submissions through coordination with other departments and research of ... a team member in the product manager area of Regulatory Affairs (Biopharma) supporting global submissions for various areas of the business. This could include… more
- Vera Therapeutics (Brisbane, CA)
- …Responsibilities: * Provides strategic direction and oversight in the preparation of regulatory submissions . * Leads teams to deliver successful submissions ... execution. * Develop and contribute to content, format and accountability for regulatory submissions and related amendments and supplements and, including… more
- Globus Medical, Inc. (Audubon, PA)
- …medical device development and registration of products + Demonstrated knowledge of US regulatory submissions ; Pre-Sub, and 510(k); working knowledge of IDE and ... PMA submissions a plus + Experience assessing regulatory impact of product/process changes + Experience reviewing labeling, promotional literature, etc. +… more
- Cardinal Health (Columbus, OH)
- …applies subject matter expertise to provide services in technical writing and regulatory submissions as well as clinical research and manufacturing process ... and risks for products and develops plans for product development programs and regulatory submissions . **_Job Summary_** The Manager, Regulatory Affairs… more
- Fresenius Medical Center (Tampa, FL)
- …operational activities within Regulatory Affairs for the preparation of regulatory submissions required to market new or existing licensed pharmaceuticals ... Responsible for the preparation, compilation, quality check and delivery of regulatory submissions in both paper and/or electronic format in accordance with… more
- Eurofins (Davis, CA)
- …follow-up of submissions under review + Coordinate, prepare, or review regulatory submissions for domestic or international projects + Interpret ... technical review of data or reports that will be incorporated into regulatory submissions to assure scientific rigor, accuracy, and clarity of presentation +… more
- Takeda Pharmaceuticals (Boston, MA)
- … regulatory regional leads, other functions and vendors to ensure global regulatory submissions are provided to local Takeda affiliates in compliance with ... field and 4 years of prior experience. Prior experience must include: Regulatory submissions to US FDA, EU, and other international health authorities: Manage… more
- Actalent (Agoura Hills, CA)
- …approvals from worldwide regulatory bodies. From developing and authoring regulatory submissions to providing critical input on cross-functional project ... and quality system procedures. + Reviews protocols and reports to support regulatory submissions . + Maintain proficiency in global quality and regulatory … more
- AbbVie (North Chicago, IL)
- …enable first pass approvals. Develops and manages content strategy for regulatory submissions , including INDs/CTAs and amendments, new marketing applications, ... + Prepares CMC regulatory product strategies. Prepares and manages regulatory submissions , including new applications and amendments, renewals annual… more
- Abbott (St. Paul, MN)
- …Additionally, will coordinate preparation of well organized, complete and scientifically sound regulatory submissions as well as interface directly with various ... Demonstrate excellent project management skills to plan for, lead and author regulatory submissions in key markets (including US and EU) for new, complex… more
- Kelly Services (Valencia, CA)
- …Your expertise will contribute to creating and executing successful strategies for regulatory submissions , ensuring on time product approvals. **Schedule:** * ... members embedded in project core teams, ensuring they effectively represent global regulatory requirements, manage timelines for submissions and approvals, and… more
- Abbott (Alameda, CA)
- …life Sciences, Biology (or equivalent vocational qualifications) + Experienced in regulatory submissions for Pharmaceutical, in vitro diagnostic devices and/or ... regulations or with EU and other international medical device regulations and submissions . + Familiar with relevant regulatory requirements for medical devices,… more
- Caldera Medical (Westlake Village, CA)
- …approvals from worldwide regulatory bodies. From developing and authoring regulatory submissions to providing critical input on cross-functional project ... and quality system procedures. * Reviews protocols and reports to support regulatory submissions . * Maintain proficiency in global quality and regulatory … more
- Lilly (Indianapolis, IN)
- …lead preparation, review, and finalization of CMC documents for global regulatory submissions , including Clinical Trial Applications, Market Authorization ... and regulatory efforts of the team, overseeing CMC regulatory activities for global submissions and interactions with regulatory authorities for Lilly's… more
- Integra LifeSciences (Braintree, MA)
- … regulatory strategies, and revise technical documentation for existing and new regulatory submissions . + Lead in the development of US and International ... submissions (510k, PMA, BLA) with minimal supervision. Ensure timeliness of regulatory submissions according to business needs. This includes ensuring prompt… more
- Sumitomo Pharma (Columbus, OH)
- …is responsible for the preparation, coordination and monitoring of routine US regulatory submissions and responses to health authority (HA) information requests. ... with HAs + Leads the preparation, coordination and monitoring of routine US regulatory submissions (eg, IND/NDA submissions , annual reports, investigator… more
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