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Request eCTD application numbers as needed from regulatory health authorities Submit electronic submission via ESG or physical media Provide technical direction for others Prepare, compline, scan, render, and maintain regulatory submissions to regulatory health authorities Prepare documents for electronic submission publishing by using MS Word formatting, content templates or MS Word Styles as dir
Posted 3 days ago
OF POSITION Independently prepares reviews and submits high quality regulatory submissions to the FDA within company timelines and in accordance with regulatory guidelines and applicable federal laws. Submissions include Annual Reports, amendments, ANDA's and supplements to ANDAs or NDAs. Gives input to established objectives and goals. Applies advanced knowledge of the pharmaceutical development
Posted 4 days ago
A collective energy and ambition. A place where you can make a real difference. We're a company that genuinely cares about our people, our products, our consumers and the environment. Our unique, informal culture champions courage, determination and collaboration. Knowing we have an open and supportive team means each of us has the freedom to take responsibility and ownership. We have a shared pas
Posted Today
OF POSITION Manages team and leads Regulatory Associates and/or Senior Regulatory Associates in regulatory activities associated with planning, authoring, compiling and submitting highest quality regulatory submissions to the FDA within company timelines and in accordance with regulatory guidelines and applicable federal laws. Plans, coordinates, authors and critically reviews submissions to FDA e
Posted 4 days ago
OF POSITION Independently authors, compiles, reviews and submits high quality regulatory submissions to the FDA within company timelines and in accordance with regulatory guidelines and applicable federal laws. Plans, coordinates and writes, clear, concise and accurate, responses to inquiries from FDA resulting from their review of the submissions. Submissions will include ANDAs, Amendments, Suppl
Posted 4 days ago
ISN Corporation
- New York, NY / Newark, NJ
HUD Project Manager Various, locations in, New Jersey & New York, United States Full time Company Description Headquartered in Bethesda, Maryland, ISN Corporation is a nationwide provider of specialized professional services to Federal government agencies. ISN's portfolio includes work with over 100 Federal agencies. ISN Corporation has been awarded a place in the Washington Business Journal&
Posted Today
The Regulatory Compliance Supervisor is responsible for overseeing and providing regulatory support and guidance to divisions, vessels, and departments with regards to compliance of documentation, statutory requirements, CFR references and other issues that arise. Essential Job Functions Provide input to policies, procedures, and document certifications Provide guidance on regulatory compliance in
Posted 2 days ago
Ortho Clinical Diagnostics
- Raritan, NJ / Pompano Beach, FL / Rochester, NY
Provide regulatory support to Transfusion Medicine, Donor Screening and Clin Labs project teams in terms of submission requirements, timing, and risks. Interact with US FDA and/ or International regulatory personnel to define submission content, expedite pending applications, and resolve regulatory matters. Prepare submissions to meet regulatory agency expectations Support base business activities
Posted 10 days ago
Site Name USA New Jersey Warren Posted Date Apr 21 2020 Are you looking for a role in which you will be responsible for end to end regulatory activities for the assigned portfolio? As a Regulatory Affairs Manager you will execute well constructed and considered regulatory strategies that keep pace with the dynamic supplement and food regulatory environment. This role will provide YOU the opportuni
Posted Today
WPS Health Solutions
- Madison, WI / Green Bay, WI / Phoenix, AZ / 15 more...
This role will act as a finance lead for developing government contract pricing strategies, models, and narratives in support of WPS Health Solutions’ existing contracts and for new growth opportunities. In this role you will Develop competitive proposal pricing strategies for proposals of all sizes and contract types Manage Disclosure Statement process including maintenance and revisions as
Posted 9 days ago
Site Name USA New Jersey Warren Posted Date Jul 7 2020 This position has responsibility for end to end regulatory activities for the assigned portfolio. Develops and executes well constructed and considered regulatory strategies that keep pace with the dynamic supplement and food regulatory environment. Builds strong relationships with all stakeholders, internal and external. This role will provid
Posted Today
Boldly Grow the Good in business and life. It calls on us to create lasting, positive change for our customers, our communities and our people. By working together, innovating and pushing boundaries, we transform lives and businesses, and power economic growth around the world. As a member of the BMO Harris Bank team you are valued, respected and heard, and you have more ways to grow and make an i
Posted Today
Assist in the preparation of post approval submissions for NDA/IND to appropriate regulatory agencies, including Annual Reports, periodic safety updates, supplements, amendments, meeting requests, briefing packages. Provide support of the regulatory document management such as archiving published submissions and agency correspondences, creating and maintaining chronology logs. Critically review su
Posted Today
AND QUALIFICATIONS Your Impact Key responsibilities include Support a dynamic team to complete quality filings with respective global regulators on a recurring basis. You are expected to provide thought leadership, recommend constructive actions to make the filing process more efficient/effective, and execute on those recommendations. You will be aligned with specific trading desk(s), functional d
Posted 2 days ago
Mission Seeking a highly energetic and motivated individual to bring Regulatory expertise to an International Cosmetics Regulatory and Safety group supporting R&D to deliver fast paced Beauty Care products to the market. Major Duties The work entails collaborating with multiple corporate functions (R&D, Legal, Marketing, Artwork Department, Safety, Project Management, etc) to ensure on time delive
Posted 9 days ago
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