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

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

FuturePlan is the nation's largest third party administrator (TPA) of retirement plans, partnering with advisors in all 50 states. FuturePlan delivers the best of both worlds high touch personalized service from local TPAs backed by the strength and security of a large national firm, Ascensus. Our roots go back decades, with nearly 30 outstanding legacy firms now joined t

The Montgomery County Correctional Facility constitutes a critically essential operating element of the Montgomery County Criminal Justice System. Its operation is directed by federal, state, county laws, standards and regulations. Montgomery County Correctional Facility staff is responsible for the overall operation of its facility, including security, enforcement of est

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

What success looks like in this role Engage with C level executives at our most strategic customers Drive innovation and setup deal structures aligned to the specific deal with associated economics Align to and provide support to deal team to get deals closed Help create the customer's AI business strategy You guide customers as they re imagine and document their digital

Supervise a team of front line QC Scientists. Performs administrative duties, i.e. hiring, performance management and supporting your team's development goals Schedules and assures adherence to schedule for the performance of analytical testing for biochemical analysis, so that all testing to support the production and release of product lots is performed in compliance wi

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 owner

Implementation Implementation Associate Capital Excellence Who You'll Work With You will work in one of our North American offices with the McKinsey Implementation (MI) team a rapidly growing capability for our firm. MI provides continuous, distinctive support to our clients to ensure they achieve and sustain the full benefits of McKinsey's recommended changes. Our implem

We have an exciting career opportunity at the center of a rapidly growing global asset management firm. The Senior Compliance Manger will be part of the client solutions compliance team and will play an integral part of supporting client facing activities for the public markets business. At Macquarie, we are working to create lasting value for our communities, our clients

We have an exciting career opportunity at the center of a rapidly growing global asset management firm. The Senior Compliance Manger will be part of the Core Compliance team and will play an integral part of driving governance and implementing compliance frameworks. At Macquarie, we are working to create lasting value for our communities, our clients and our people. We ar