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Director of Regulatory Affairs

Company: Sagent Pharmaceuticals
Location: Schaumburg
Posted on: March 22, 2020

Job Description:

Reporting to the Vice-President of Regulatory Affairs, the Director of Regulatory Affairs is responsible for all activities of the Regulatory Affairs Department with primary responsibility being to file and obtain ANDA approvals and ensure compliance with FDA regulations. Sagent is seeking a hands-on leader who is a doer and can think outside the box. You must have an unrelenting drive to execute on Abbreviated New Drug Applications (ANDAs) with the FDA"s Center for Drug Evaluation and Research, Office of Generic Drugs. The Director of Regulatory Affairs will be expected to: Successfully build lasting relationships with our worldwide partners, and the manufacturing team through frequent contact and regular participation in meetings, and teleconference calls to ensure that R&D, Quality Control and Production activities meet FDA requirements. Analyze the ANDA approval process within Sagent to introduce and adopt best practices to ensure rapid, correct submission of ANDAs. You will be the key driver to develop systems to ensure FDA compliance. Successfully build relationships with FDA"s Center for Drug Evaluation and Research, Office of Generic Drugs through frequent contact and regular participation in teleconference and online meetings to ensure that the ANDA submittals for Sagent Pharmaceuticals are fully compliant and rapidly approved. Deeply understand our production and Quality Control operations at all our facilities (internal and CMOs) to drive process improvements and FDA compliance. Regularly check Labeling with R&D to determine the need for revisions. Review and response to FDA requests to ensure that changes are required, submitted and implemented. The ideal candidate will have demonstrated proficiency and /or experience in the following areas: As an "A" level team leader, you will be expected to set the example for your team, and lead by showing how things can be done better, and smarter. You should be an expert on FDA approval processes. The ideal candidate will have the ability to: Manages accuracy of technical documentation for regulatory submissions for NDAs, ANDAs, amendments, supplements, and annual reports that meet regulatory standards. Provides regulatory strategy and maintenance of approved products. Ensures a clear understanding of post-approval regulations and requirements Work with the FDA and international regulatory agencies and be experienced at responding to FDA/HA deficiency notices and participating in FDA audits. Candidate Must Have Qualifications: Bachelor"s degree in a Scientific Field of study, Master"s degree or Ph.D. preferred 10+ years of regulatory experience with USA regulatory expertise preferred and proven advancement to leadership position and 3+ years of in a supervisory position Experience in pharmaceutical/life sciences industry, and/or generic registration experience Experience writing and assembling the supporting documentation for INDs, ANDAs, and NDAs; BLA experience preferred Regulatory post approval change control assessment activities including site changes, process changes, and vendor changes for internal and CMO manufacturing sites Pre-development, IND and Post Approval for NDAs preferred Expertise in filing, obtaining product approvals and launching ANDAs and/or NDAs 10+ years of experience in generic pharmaceutical industry, preference for solids, liquids, topicals, injectables, solutions or suspension HOW TO APPLY - All resumes should be forwarded to Your submission should include responses to the following questions: What is the candidate"s experience preparing, filing and obtaining ANDA approvals in a generic pharmaceutical company? What is the candidate"s experience leading change with quality control and production partners? What is the candidate"s experience managing and motivating team members? Sagent Pharmaceuticals is an EEO/AA employer and does not discriminate on the basis of race, color, religion, sex, age, creed, national origin, veteran status, physical or mental disability and sexual orientation.

Keywords: Sagent Pharmaceuticals, Schaumburg , Director of Regulatory Affairs, Executive , Schaumburg, Illinois

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