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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 Sr. Regulatory/Quality Compliance Scientist. Job located in Hauppauge, NY. Review, approve, maintain, and provide training on controlled GMP documents.Manage document control. Issue and maintain all controlled documents such as SOPs, method validation protocols
and reports, methods, batch records, equipment/process qualification protocols and reports, change controls,specifications, and other quality-related GMP documents.
Conduct audits to assure all activities are performed in accordance with current FDA regulations, ICH guidelines, cGMPs and cGLPs.Supervise raw material release sampling and retesting. Assist with routine and PAI FDA inspections and assure that the facility is in a state of compliance.Provide regulatory input for deviations, out of specifications (OOS) investigations, batch failures,and customer complaints. Monitor follow-up actions with CAPA program. Assist in preparation of regulatory submissions including ANDAs and NDAs as per current US FDA requirements. Requires Master’s degree or foreign equivalent in Pharmaceutical Sciences,Regulatory Affairs, Life Sciences, or related and 1 year 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; Job 15SAP02; EOE