Coordinates and prepares document packages for regulatory submissions for new and mature products, ensuring compliance with local and regional registration requirements. Compiles all materials required in submissions, license renewal and annual registrations. Recommends changes for labeling, manufacturing, marketing and clinical protocol for regulatory compliance. Monitor

The FDA Center for Tobacco Products requires the assistance of minors ages 16 17 and those under age 18 20 to attempt the purchase of tobacco products from local tobacco retailers. The goal of the program is to ensure tobacco retailers are complying with Federal laws and regulations that prevent them from selling tobacco products to minors. This will be a part time, posit

Ecologist Job Locations US PA Athens Category Ecological Services Type Full Time Overview As an Ecologist for Civil & Environmental Consultants, you'll work with project teams to navigate today's complex environmental regulatory landscape, helping our energy, commercial, and institutional clients to achieve and maintain compliance with regulatory criteria. You'll assist i

Manage regulatory team members by communicating clear priorities and focused objectives in line with short and long term business plans. Drive the development and execution of regulatory strategies and tactical plans for registration of products in the US and Canada. Lead the preparation, submission, and approval of quality US EPA submissions. Ensure compliance with all a

Manage all aspects of submissions relevant to assigned projects and programs, in accordance with submission and regulatory requirements. Lead cross functional groups across the organization in the development of global regulatory strategy to complete developmental and post approval regulatory submissions. Define contributions for submissions, communicate to functional con

Senior Regulatory Affairs Associate Experience Biologic CMC 5+ years of experience Supported the CMC activities related to Vaccine/Biologic manufacturing and control including authoring of submission dossiers related to new application, post approval variations Understanding of EU/CA/WHO/US regulations & guidance allowing appropriate review and compilation of data to appr

Benefits Start Day 1 for Full Time Colleagues No Waiting Period! For more information about our benefits, see below! We are proud to be a member of the Rentokil family of companies, the global leader in Pest Control and other services across more than 90 countries. We pride ourselves on being a trusted partner to many of the world's leading brands and serve consumer and b

Develop and administer trade compliance training to functional teams to enhance competencies in operational business scenarios. Collaborate with legal, finance, tax, and other functions as needed to make relevant trade compliance determinations. Develop, maintain, and communicate standards to operational teams via master data or other databases to facilitate business flow

/JOB PURPOSE Responsible for managing and maintaining existing investigational new drug (IND) and clinical trial application (CTA) submissions and preparing amendments in compliance with guidelines and regulations. Coordinates, compiles, and tracks product applications to regulatory agencies. Essential Duties And Responsibilities Review clinical site regulatory documents t

A valid driver's license and full time usage of reliable transportation are required. Driving is an essential function of the job and Motor Vehicle Records may be checked as part of the hiring process or at any time during employment Required to carry sufficient motor vehicle insurance Accurate and efficient typing capabilities (40+ WPM recommended) and ability to work wi

PRIMARY FUNCTION The Regional Compliance Officer (RCO), Thomas Jefferson University, collaborates with Jefferson enterprise compliance team members to establish and implement an effective compliance program designed to identify and manage high risk activities at the regional and enterprise levels. The RCO will monitor and oversee Jeffersonrsquo;s compliance and ethics rel

Participates in and identifies specific tests while executing test scenarios for unit, process, function, system integration, regression and acceptance testing. Defines criteria for testing, analyzes results of testing sessions and presents testing results to project stakeholders. Reviews applicable requirements in order to develop complex test cases, scenarios and script

Under the general direction of the Director of Regulatory Affairs, executes the hospitalrsquo;s regulatory readiness processes to assure compliance with regulations and standards of regulatory and accreditation agencies. Assesses and determines survey readiness and compliance to all accrediting and licensing agencies by identifying areas of noncompliance and works with le

Benefits At Vibra Healthcare, employees are our priority. We are passionate about patient care and consider it a privilege to be able to provide services to patients and their family members. Below is a brief summary of our benefits. Medical PPO high and low deductible plans / HSA options as well as HMO options in some markets FREE prescription plans Dental and Vision cov

Milton Hershey School (MHS) is one of the world's best private schools, where students from lower income families who are looking for greater opportunity are able to explore their individual interests to the fullest. Thanks to the generosity of Milton and Catherine Hershey, the school is fully endowed with the resources to ensure every child and staff member has what they