Description:

　　Regulatory Affairs Specialist

　　Research regulations to support regulatory strategies.o Specifically, research regulations, guidance’s, USP, and/or other available standards/literature, then present them in writing for approval.

　　Collaborate on regulatory projects regarding the manufacturing transfer of acquired ANDA filings, including, but not limited to:o Manage project timelines and cross functional teams for supplements.

　　o Authoring supplements or providing authoring support.

　　Manage annual ANDA filings:o Submit Annual and Periodic Reports

　　o Prepare

　　o Submit Periodic Reports

　　Assess change controls for regulatory impact of ANDA applications. Manage associated projects required regulatory submissions.o Including CCS’, API changes, USP updates

　　Provide regulatory customer support for product launching.Diversity, Equity & Inclusion

　　At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:

　　Hiring diverse talent

　　Maintaining an inclusive environment through persistent self-reflection

　　Building a culture of care, engagement, and recognition with clear outcomes

　　Ensuring growth opportunities for our people

　　Actalent is an equal opportunity employer.

　　About Actalent

　　Actalent connects passion with purpose. We help visionary companies advance their engineering and science initiatives through access to specialized experts that drive scale, innovation, and speed to market. With a network of almost 30,000 engineering and sciences consultants and more than 4,500 clients across the U.S., Canada, Asia, and Europe, Actalent serves many of the Fortune 500. An operating company of Allegis Group, the global leader in talent solutions, Actalent launched as a new specialized engineering and sciences services and workforce solutions brand in 2021.