Remote Associate Director/Director for Regulatory Affairs

Padagis US LLC is seeking an experienced and dynamic Director or Associate Director of Regulatory Affairs that will be responsible for overseeing regulatory strategies, submission requitements and writing for pharmaceutical products targeted for the U.S. market. Majority of the submissions are ANDAs for generic products in a variety of dosage forms such as complex oral solids, injectables, transdermal, and sterile ointments. In this pivotal role, you will work cross-functionally with internal teams and external stakeholders to ensure regulatory compliance, provide consultation on regulatory aspects during the development phase, ensure all activities are planned and executed for a successful submission. This position plays a critical role in guiding products through the development pipeline, securing FDA approval, and establishing a strong foundation for market entry. Note: This is a remote workplace eligible position for candidates residing in the United States, with preference given to candidates in the Minneapolis-St. Paul, Minnesota area. Job duties: Regulatory Strategy Development : Develop and implement comprehensive regulatory strategies to support the development phase according to the current FDA guidances and recent trends. Provide regulatory leadership during all phases of product development, including preclinical, clinical, and manufacturing stages, ensuring alignment with FDA standards and guidelines. Assess and mitigate regulatory risks, ensuring anticipated challenges are addressed proactively. Regulatory Submissions and Approvals: Oversee the preparation, submission, and management of high-quality regulatory documentation, including INDs, NDAs, ANDAs, and amendments to the FDA. Plan and execute submission timelines to ensure timely filings and approvals within project deadlines. Collaborate with cross-functional teams, including R