OF POSITION Independently authors, compiles, reviews, and schedules high quality regulatory submissions in adherence with standards that are fully compliant with FDA and ICH requirements within company timelines. Plans, coordinates and writes, clear, concise and accurate, responses to inquiries from FDA resulting from their review of the submissions. Submissions will inclu

Under the direction and supervision of the Transparency Manager, the TRS will accomplish the following job duties . Provides a variety of high level program support functions; reviews and processes documents; determines and explains compliance with laws, rules, regulations and policies and takes appropriate action; maintains a manual or computerized records system; perfor

& Scope of Position Manage assigned regulatory projects and/or submissions ensuring that Company products comply and meet national and international regulatory requirements and standards. Primary Responsibilities Coordinates and prepares (i.e., plans, writes, and reviews) timely submissions, including interfacing with other departments to obtain the necessary components an

Review and update current KM/BP policies and draft KM/BP strategies with recommendations for changes and realignment with DOD instructions, Federal law, industry standards, external best practices, and other guidance as applied to Federal and Government Knowledge management and Business Process Reengineering, Improvement and Management. Provide recommendations, developmen

Who we are LANXESS is a leading specialty chemicals company with sales of EUR 7.6 billion in 2021 and more than 13,000 employees in 33 countries. The core business of LANXESS is the development, manufacturing and marketing of chemical intermediates, additives, specialty chemicals and plastics. LANXESS is listed in the leading sustainability indices Dow Jones Sustainabilit

A Day in the Life In House Counsel, Transportation Contract Specialization Are you a detailed individual who is looking for a position with a leading organization that is committed to innovation and excellence and dedicated to transforming the 3PL industry through cutting edge solutions? Our team is driven by a passion for pushing boundaries and creating impactful change.

Government of the District of Columbia Office of the Chief Financial Officer (OCFO) Accounts Payable Supervisor $72,706.00 $93,742.00 The Office of the Chief Financial Officer (OCFO) whose mission is to enhance the fiscal and financial stability, accountability and integrity of the Government of the District of Columbia is in search of a Accounts Payable Supervisor . This

Great opportunity for Analyst Trainer with large government contractor!

of this role includ e , but are not limited to Create strategy and win themes for project pursuit deliverables including qualification statements, proposals, and presentation materials by leading pursuit teams and writing, editing, and graphic layout of the documents meeting all requirements, deadlines, and delivering the highest level of quality. Guide, coach, and manage

Lead Chatham's US Regulatory and Documentation practice, a unified team supporting all of our client sectors in navigating applicable regulations Collaborate with the International Regulatory and Documentation practice lead to ensure an appropriate degree of alignment in processes, priorities, and talent development Partner effectively with stakeholders outside of direct

Make an impact by joining ServiceSource, a champion for people with disabilities.Explore new opportunities! ServiceSource is an organization of talented people who drive innovation, embrace change, and serve humanity. Job Summary The Recycling Laborer is responsible for ensuring materials are properly disposed of, in accordance with federal regulation and contract guideli

The Senior Manager, Regulatory Information Management (RIM), will work closely with R&D and Manufacturing well as other functions within Jazz, to manage training, documentation, user experience, and maintenance of the RIM system and integration with the other systems at Jazz Essential Functions Understand the business processes (across R&D and Manufacturing), regulatory a

At Mitratech, we are a team of technocrats focused on building world class products that simplify operations in the Legal, Risk, Compliance, and HR functions of Fortune 100 companies. We are a close knit, globally dispersed team that thrives in an ecosystem that supports individual excellence and takes pride in its diverse and inclusive work culture centered around great

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Work closely with functional business groups to ensur

Administer, manage, implement, and maintain USSOCOM’s cloud and on prem infrastructure services. Collaborate with engineers and USSOCOM government technical staff to ensure seamless integration of hardware, software, and firmware across an array of network solutions. Monitor network performance and troubleshoot issues as they arise. Configure and maintain firewalls,