- Actalent (Cambridge, MA)
- Job Title: Regulatory Submissions Specialist Job Description We are seeking a highly skilled Regulatory Submissions Specialist to manage ... and CMC leads to create content plans and submission timelines for regulatory submissions . + Organize and facilitate kick-off meetings and comment resolution… more
- ICON Clinical Research (Brentwood, TN)
- …Team (CDPRT) and Sponsor. **What you need for Study Start Up Associate I - Regulatory Submissions ** * A high school diploma or local equivalent * Bachelor's ... Competent Authority (CA), Ethics Committee (EC) and Institutional Review Board (IRB) Submissions + Collect, review, organize and assemble regulatory initial… more
- J&J Family of Companies (Spring House, PA)
- …summaries for INDs, CTAs, BLAs/NDAs/MAAs, Investigator's Brochures, annual updates to regulatory submissions (eg, DSURs, PBRERs, NDA annual reports), briefing ... of success in planning and implementing nonclinical submission support in global regulatory submissions preferred. + Expertise in multiple modalities, such as… more
- Regeneron Pharmaceuticals (Troy, NY)
- …global markets. + Lead the preparation, coordination, and compilation of CMC regulatory submissions for non-US/EU markets in accordance with local regulations ... international health agencies in support of the CMC modules of regulatory submissions . + Keeps all stakeholders, including external partners, informed of… more
- MD Anderson Cancer Center (Houston, TX)
- …SPECIFIC COMPETENCIES Provides high level strategic and operational direction of the Regulatory Submissions group within the Office of Clinical Research. Leads ... preparation and maintenance. Ensures high-quality and timely delivery of IND/IDE regulatory submissions in compliance with all applicable regulatory… more
- LSI Solutions (Victor, NY)
- … Specialists assigned to Domestic Regulatory Projects will 1) prepare regulatory submissions , including FDA Q- Submissions , 513(g) Submissions , ... Regulatory Projects will 3) work with distributors to prepare regulatory submissions required to market LSI's new or modified medical devices outside the… more
- Spectrum Plastics Master (Tucson, AZ)
- … guidance throughout the product development cycle and coordinating team inputs for regulatory submissions . + Communicate with regulatory agencies regarding ... or clinical study compliance issues. + Determine the types of regulatory submissions or internal documentation that are required in situations such as… 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
- Fresenius Medical Center (Waltham, MA)
- …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
- Actalent (Bridgewater, NJ)
- …NJ. Reporting to the Chief Scientific Officer, this position will lead our regulatory submissions as well as preside over the company's regulatory ... strategy for pipeline projects, evaluate new product opportunities, and manage regulatory submissions . + Serve as the primary point of contact with global … more
- Teleflex (Maple Grove, MN)
- …projects. * Reviews product development to assure collection of appropriate data for regulatory submissions and regulatory compliance. * Interact and ... solutions that make a difference in patients' lives. **Position Summary** The Regulatory Affairs Specialist will develop strategies, submissions , and … 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 ... global regulatory strategies for all devices and preparing and submitting regulatory submissions in the both the US and OUS geographies. * Prepare Technical… more
- United Therapeutics (Silver Spring, MD)
- …strategy, providing regulatory advice and oversight to project teams and supporting regulatory submissions and department activities. This role serves as a ... strategies, managing documentation needs and timelines, and supporting preparing and executing regulatory submissions . This is a hybrid position with 3 days/week… more
- Lilly (Indianapolis, IN)
- …submission or minimize risk. * Reviews and approves CMC documents for global regulatory submissions , including submissions for manufacturing changes, new ... Affairs CMC to be a part of the Lilly Global Regulatory Group to support global submissions and registrations. As the Project Leader, you will be expected to… more
- J&J Family of Companies (Cincinnati, OH)
- …product development stages and generating submission ready documentation and authoring regulatory submissions . Additionally, this individual will support health ... , IDEs, De Novo, 510(k)s) and global health authorities' submissions technical documents. + Serves as a Regulatory... submissions technical documents. + Serves as a Regulatory Affairs subject matter expert on new product development… more
- MicroVention, Inc. (Aliso Viejo, CA)
- …that span outside of immediate job area. + Write, review, and file regulatory submissions to ensure MicroVention devices are commercially available in the ... regulatory agencies through oral and written communications regarding pre- submissions strategies, potential regulatory pathways, compliance test requirements,… more
- Takeda Pharmaceuticals (Boston, MA)
- …regulatory subteam (GRT) and, cross-functional subteams and working group to execute regulatory submissions . Assists in the creation and submission of high ... within defined timelines as per R&D and business objectives. + Responsible for regulatory submissions for assigned programs. Works cross-functionally with RA and… more
- Integra LifeSciences (Harrisburg, PA)
- … strategies, and create and revise technical documentation for existing and new regulatory submissions . + Prepares regulatory strategies with minimal ... and response to questions with minimal supervision. + Ensure timeliness of regulatory submissions according to business needs. This includes ensuring prompt… 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
- Abbott (St. Paul, MN)
- …robust global regulatory strategies, working with cross-functional teams as the regulatory SME, compiling regulatory submissions , and ensuring data is ... acceptability of documentation for Class III and Class II medical device submissions and effectively communicate regulatory guidance. + Compile, prepare, review… more
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