Job Description:

　　Responsible for researching regulations, guidance’s, USPs, and other standards for regulatory strategies.

　　Present written strategies for approval.

　　Work in conjunction with regulatory group regarding the manufacturing transfer of acquired ANDA filings including authoring supplements, providing authoring support, and managing project timelines and cross functional teams.

　　Manage annual ANDA filing and prepare and submit annual and periodic reports.

　　Evaluate change controls for regulatory impact of ANDA applications.

　　Manage projects associated with regulatory submissions including API changes, USP updates, and CCS’.

　　Provide regulatory customer support for new product launches.

　　Qualifications:

　　Minimum education of Bachelor’s Degree.

　　5+ years of experience within the regulatory field.

　　Prior experience with manufacturing site transfers of ANDA products.

　　Experience with FDA submissions in eCTD format.

　　Experience with monograph items and repackaging of drug products is a plus.

　　Strong attention to detail and ability to collaborate with cross functional teams.

　　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.