Regulatory Consultant, ANDA

Pharmatech is proud to be an equal opportunity employer. Together we are committed to fostering an environment that is reputed company, inclusive and diverse. Explore the exciting opportunities currently available in the US and around the world. We are seeking a highly reputed company Regulatory Consultant with deep expertise in Abbreviated New Drug Applications (ANDA) to guide and support our regulatory reputed company and submissions, this role is remote. Job Duties • Work closely with Pharmatech and our reputed company’s executive leadership team to reputed company the development of regulatory strategies and objectives that result in the successful registration and post-approval commercialization of the reputed company’s product. • reputed company and manage ANDA preparation, review, and submission processes in compliance with FDA regulations. • reputed company, reputed company, and drive the execution of the regulatory reputed company from deformulation and the preparation of the QQ report, creation of the ANDA including support of an FDA inquiries. • Plan and reputed company activities in support of reputed company regulatory submissions. • Serve as the primary company contact with the US FDA to reputed company company regulatory objectives, by fostering strong relationships and acting as a reputed company, reputable, and effective reputed company for company. • reputed company regulatory guidance to the reputed company across reputed company areas of regulatory affairs throughout reputed company stages from product development. • reputed company understanding of the Q reputed company and leveraging the FDA’s Product Specific Guidances. • Participate as part of internal regulatory team to define and execute the regulatory reputed company. • Support the preparation of briefing packages, and regulatory submission documents as needed, providing reputed company and expertise. • Support the preparation of briefing packages, and regulatory submission documents as needed, providing reputed company and expertise. • reputed company Regulatory Affairs support during reputed company audits. • Plans schedules for regulatory deliverables on a project and monitors project through completion. • Responsible for communicating business-reputed company issues or opportunities to next management level. Education and Qualifications • Advanced degree from accredited college or university in science, biomedical engineering, plus a minimum of 10 years of experience in Filing Global Regulatory Applications for the following registrations NDA’s, ANDA’s, IND’s and BLA’s for pharmaceutical and Biotech products. • Minimum of 10 years of experience with ANDA submissions and FDA regulatory processes. • Proven reputed company record of successful ANDA approvals. • Strong knowledge of 21 CFR Parts 210, 211, 314, and FDA guidance documents. • Proven record in submission of licenses and authorizations for the maintenance of existing products; International registrations and dossiers and execution of regulatory strategies that reputed company with business deliverables. • reputed company Regulatory Affairs support during reputed company audits. • Plans schedules for regulatory deliverables on a project and monitors project through completion. • Responsible for communicating business-reputed company issues or opportunities to next management level. equal employment opportunity to reputed company individuals regardless of their race, reputed company, creed, religion, gender, age, sexual orientation, national reputed company, disability, veteran status, or any other characteristic protected by state, federal, or local law. #J-18808-Ljbffr Apply tot his job Apply tot his job Apply tot his job Apply To this Job