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At Saptalis, you will have the opportunity to work with a talented team, experience many challenges and grow professionally. As part of a relatively small but focused and rapidly growing company, you can make an impact on its success. We aim to bring affordable quality medicines quickly to market, and be a leader in several niche pharmaceutical areas. We have many exciting days of steady growth ahead of us due to our new product pipeline.

Saptalis Pharmaceuticals, LLC has a job opening for Manager, Regulatory Affairs. Job located in Hauppauge, NY. Prepare regulatory submissions including ANDAs and NDAs according to U.S. FDA requirements. Provide necessary updates to submissions or responses to resolve any filing deficiencies. Review and approve all the required technical documentation to develop a product and successfully transition to commercial manufacture. Handle the post-approval regulatory activities such as filing annual reports and PADERs once the products are approved. Evaluate,advise, and approve regulatory impact of changes to manufacturing processes, specifications, and components. Coordinate external audits and inspections of the facility by regulatory agencies.Provide regulatory input for deviations, out of specifications (OOS) investigations, batch failures, and customer complaints. Supervise the implementations of pharmacovigilance program according to FDA requirements. Work with various tools such as eCTD software and SPL Editor. Requires Master’s degree or foreign equivalent in Regulatory Affairs, Chemistry,Engineering (any), Pharmacology, Life Sciences, or related and 1 year of experience in the job offered or as a Regulatory Affairs Professional. Offered salary $99,000 P/Y. Mail resume with cover letter to Saptalis Pharmaceuticals, LLC, 45 Davids Drive, Hauppauge, NY 11788;  or email Job 17SAP04; EOE