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A leading specialty pharmaceutical company with fully integrated technology development, product development, manufacturing, and commercialization capabilities.
We are seeking talented professionals to be a part of our dynamic and diverse team of over 500 employees. We currently have an opening for a Sr. Regulatory Affairs Associate.
ESSENTIAL DUTIES AND RESPONSIBILITIES
Coordinates company activities to ensure the timely submission and approval of applications, amendments, supplements, and other regulatory correspondence. Compiles data and documents into FDA-acceptable format (including electronic) for filing as a New Drug Application (NDA), an Investigational N-ew Drug (IND) application, an Abbreviated New Drug Application (ANDA), an amendment to NDA/ANDA, and/or a supplement to NDA/ANDA. Ensures that the data and documents provided are complete and correct. Interacts with appropriate departments (i.e., Project Teams) to obtain missing information and correct erroneous information that is intended for submission. Tracks the status of submissions as they progress through the regulatory review process. Represents the Regulatory Affairs department in interdepartmental meetings, including Project Teams, pertaining to new product development, approval, and launch. Participates in pre-approval inspections of those applications for which the employee was responsible for submission. Corresponds with FDA, via written and/or verbal media, to request meetings, discuss agency comments, and follow-up on submissions. Participates in FDA meetings regarding responsible products. Coordinates and prepares responses to FDA Deficiency Letters pertaining to those applications for which the employee was responsible for submission. Monitors the patent and exclusivity status of current product portfolio and products in R&D development. Interprets FDA policies and guidances, such as SUPAC, and correctly applies them as appropriate to the Company’s products. Prepares annual reports and periodic reports (including electronic) for submission in accordance with FDA regulations and guidances. Reviews/audits the submissions prepared by the Regulatory Affairs Associate as needed (ANDAs, annual Reports, Periodic Reports). Along with the VP Regulatory Affairs and the Regulatory Affairs Manager, manages the pre- and post-approval activities related to Investigational New Drug (IND) applications and NDA submissions. Assists less-experienced RA personnel with IND/NDA related submissions. Conducts special assignments/projects per the direction of Regulatory Affairs management. Perform other duties as assigned.
EDUCATION AND EXPERTISE
BS in a Life Science coupled with 5+ years for Senior and/or formal training in Regulatory Affairs is required. Regulatory Affairs Certification is desirable. Knowledge of Chemistry that enables the employee to evaluate analytical records and documents that are intended for regulatory review. Knowledge of pharmaceutical production that enables the employee to evaluate production records and documents that are intended for regulatory review. Knowledge of FDA regulatory requirements, particularly with IND/NDA related submissions, that enables the employee to perform effectively in this position.
BENEFITS
We offer a competitive compensation package that includes medical, dental and life insurance, Short term and long term disability insurance, 401K savings plan, paid time-off, tuition assistance and more
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