48 results for Regulatory Manager Jobs in Waltham, MA, US

A career within Regulatory Risk and Compliance services, will provide you with the opportunity to help companies rethink their approach to risk and create a sustainable risk advantage. We’re a part of a unique client proposition, assisting our clients develop proper internal controls by leveraging a...

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Responsible for supporting the business and customers by providing quality documents and regulatory support for ongoing projects, new product development, and change control. Identify and lead cross-functional activities, prepare and review regulatory support documentation, and respond to customer r...

Responsible for the development and implementation of US and Canada regulatory strategic and tactical planning for assigned products. Acts as Health Authority liaison with FDA, prepares regulatory submissions, and recommends changes to projects based on regulatory knowledge. Operates in compliance w...

Sentec seeks an energetic and seasoned Senior Manager of North American Regulatory Affairs to lead North-American Regulatory Affairs for our portfolio of products in the United States and Canada. This position reports to the Global Head of Regulatory Affairs and Quality Assurance. Candidates should ...

Who we are:Agios is a biopharmaceutical company that is fueled by connections. We thrive in a supportive, fun, and flexible environment full of people empowered to bring their whole selves to work. We care deeply about our work, each other, and the patients who count on us. Our teams cultivate stron...

Responsibilities The Director of Regulatory Affairs will be responsible for the preparation and management of ANDA submission and oversee and manage all ANDA regulatory activities pre- and post- submission. This role is critical in ensuring that products meet all regulatory requirements and meet th...

Responsibilities Lead the strategic efforts in the interpretation of relevant and new quality guidelines to ensure that the current and phase appropriate requirements and standards are properly and timely implemented. Provide support to Regulatory CMC managers in developing strategy for development...