- Wacker Chemical (Ann Arbor, MI)
- Senior Regulatory Affairs Specialist- FDA Food 1 1 Job Location (Short): Ann Arbor, MI, USA, 48108 Posting Start Date: 7/16/25 Do you want to take responsibility and ... we are looking for you as a(n)Senior Regulatory Affairs Specialist- FDA Food 1 1. This position is responsible for...Food 1 1. This position is responsible for leading FDA regulatory product compliance reviews for Food Additive, Food… more
- General Dynamics Information Technology (Silver Spring, MD)
- …Analyst** for new contract to support the **Food and Drug Administration ( FDA )** and their critical mission needs. As a Business Requirements Analyst, you ... our clients. Current or past experience working at the FDA in a similar capacity is required.** **This is...at the GDIT office in Gaithersburg, MD and/or the FDA office in Silver Spring, MD.** **Responsibilities:** + Assists… more
- Family Dollar (Chesapeake, VA)
- …engineering discipline. + Minimum 3 years of Quality work experience in FDA regulated industries. (pharmaceutical or medical device industry preferred). + Working ... knowledge of FDA Quality Systems (cGMP) and regulatory requirements (eg, 21 CFR Parts 111, 210, 211, 700 and 820). + Thorough understanding of Good Documentation… more
- General Dynamics Information Technology (Silver Spring, MD)
- …seeking a **Scrum Master Advisor** to support the **Food and Drug Administration ( FDA )** and their critical mission needs. As a Scrum Master Advisor, you will ... 3 out of the last 5 years required. **Preferred Skills and Experience:** + FDA experience strongly preferred. + Ability to manage multiple projects and work rapidly… more
- Family Dollar (Chesapeake, VA)
- …engineering discipline. . Minimum 3 years of Quality work experience in FDA regulated industries (pharmaceutical or medical device industry preferred). . Working ... knowledge of FDA Quality Systems (cGMP) and regulatory requirements (eg, 21 CFR Parts 111, 210, 211, 700 and 820). . Working knowledge of statistics. Full time 510… more
- DRT Strategies, Inc. (Silver Spring, MD)
- …Process Optimization project was initiated in December 2021 at the request of FDA senior leadership to provide an enterprise solution to replace the multiple Center ... to augment Agency Information Management System (AIMS), the current FDA FOIA tool used for tracking requests. Since AIMS...implemented, the volume of requests has gone up but FDA 's current technology has been unable to keep up… more
- Glenmark Pharmaceuticals Inc., USA (Elmwood Park, NJ)
- …communication to support both internal and external customers (globally) including the US FDA . Job Responsibilities Note: These statements are not intended to be an ... candidate will need to be able to review and sign various submissions to FDA . It will include ANDA cover letter, Form 356H for Original ANDAs, Amendments to… more
- DRT Strategies, Inc. (Silver Spring, MD)
- …supporting data quality, and helping with process improvements so that the FDA can efficiently review submissions and maintain business continuity. This support will ... help the FDA meet its obligations under recent legislation and ensure...SLAs and performance metrics, and effective cross-desk coordination for FDA /CDER. This role manages the SOP and FAQ repository,… more
- DRT Strategies, Inc. (Silver Spring, MD)
- …supporting data quality, and helping with process improvements so that the FDA can efficiently review submissions and maintain business continuity. This support will ... help the FDA meet its obligations under recent legislation and ensure...Responsibilities: + Oversee daily operations and maintenance support for FDA electronic submission systems and mailboxes. + Manage and… more
- Boehringer Ingelheim (Ridgefield, CT)
- …the draft CCDS. + Provide US guidance to global team on FDA submissions, meetings, and pediatric development requirements including preparation of documentation, as ... if available, taking into account US regulatory labeling precedence and FDA comments/guidance. + Pre-evaluations and External Partnerships: + Provide broad and… more
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