AllentownRecruiter Since 2001
the smart solution for Allentown jobs

Regulatory Affairs Specialist

Company: Synerfac
Location: Allentown
Posted on: November 22, 2021

Job Description:

JOB TITLE: Regulatory Affairs SpecialistSUMMARY: Local pharmaceutical company in the Lehigh Valley is looking for a Regulatory Affairs Specialist to join their team. This person will report to Vice President of Regulatory Affairs.RESPONSIBILTIIES: * Prepare submissions for New Drug and Abbreviated New Drug Applications (NDAs and ANDAs) according to ICH-CTD* Develop and assess strategies for regulatory approvals for NDAs and ANDAs by providing input for product development through commercialization. * Prepare controlled correspondence with FDA * Communicate with FDA project manager on NDA and ANDA related issues* Prepare annual reports for NDA/ANDAs by scheduling and coordinating receipt of documentation/information, preparing cover pages describing changes made to an application and tracking progress of their preparation.* Review of documents and interacting with multiple departments (QA, AS, Engineering, PD, etc.) which provide information and documentation utilizing the change control database to ensure accurate reporting to FDA.* Assist in maintaining approved NDA/ANDAs current by requesting revisions to technical documentation as part of the annual report preparation process.* Develop and assess strategies for regulatory approvals for NDAs and ANDAs by providing input for product development through commercialization. * Prepare controlled correspondence with FDA * Communicate with FDA project manager on NDA and ANDA related issues* Prepare annual reports for NDA/ANDAs by scheduling and coordinating receipt of documentation/information, preparing cover pages describing changes made to an application and tracking progress of their preparation.* Review of documents and interacting with multiple departments (QA, AS, Engineering, PD, etc.) which provide information and documentation utilizing the change control database to ensure accurate reporting to FDA.* Assist in maintaining approved NDA/ANDAs current by requesting revisions to technical documentation as part of the annual report preparation process.REQUIREMENTS:* Minimum of two years of experience in regulatory affairs* Bachelor of Science or related degreeJob Requirements:REQUIREMENTS:* Minimum of two years of experience in regulatory affairs* Bachelor of Science or related degree

Keywords: Synerfac, Allentown , Regulatory Affairs Specialist, Other , Allentown, Pennsylvania

Click here to apply!

Didn't find what you're looking for? Search again!

I'm looking for
in category
within


Log In or Create An Account

Get the latest Pennsylvania jobs by following @recnetPA on Twitter!

Allentown RSS job feeds