Description:

• Assists manager with US-based Regulatory Operations responsible for all regulatory compliance and regulatory risk strategies at the New York, Oklahoma and Canada Product Supply operations.

• Responsible for the development of CMC documentation, coordination and management of electronic submissions, including the assessment and management of commercial licence status and maintenance of product compliance including worldwide distribution of ALK-Abello, Inc. products.

• Provide product compliance support to FDA, USDA, Health Canada and other regulating international agencies.

• Department liaison for ALK-Abello, Inc. when dealing with regulatory agency submissions. Assist Manager with response to regulatory agencies observations and regulatory actions.

• Supports the preparation of CMC information for submission to global regulatory agencies, generates CMC strategies, assesses risks and develops contingency plans.

• Able to develop and/or lead projects or team initiatives to support short-term operational goals and contribute to the development of global regulatory initiatives.

• Assist manager with providing compliance site reports to the various agencies, including Annual Reports for NY and OK, Drug Master File updates, Annual Establishment Report, , Annual Source Material and Suppliers Report, Semi-Annual Distribution Reports, Annual USDA Outlines Review, and Annual Establishment and Labeling Licence Renewal.

• Leads Regulatory position for Product Supply projects when assigned by Manager.

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• Perform regulatory compliance analysis and audits to monitor compliance with federal regulations and company policies.

• Perform employee training on current US, Canada, EU and Japanese pharmaceutical laws.

• Write and maintain Standard Operating Procedures required to document regulatory compliance to federal laws.

• Other duties as assigned.

About Actalent:

Actalent connects passion with purpose. Our scalable talent solutions and services capabilities drive value and results and provide the expertise to help our customers achieve more. Every day, our experts around the globe are making an impact. We’re supporting critical initiatives in engineering and sciences that advance how companies serve the world. Actalent promotes consultant care and engagement through experiences that enable continuous development. Our people are the difference. Actalent is an operating company of Allegis Group, the global leader in talent solutions.

The company is an equal opportunity employer and will consider all applications without regards to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.