Regulatory Affairs Senior Specialist

Company: Actalent
Location: Mount Prospect
Posted on: March 20, 2023

Job Description:

Description:- Will work directly with Lori, the Regulatory Manager.1. Research regulations to support regulatory strategies.o Specifically, research regulations, guidance's, USP, and/or other available standards/literature, then present them in writing for approval. 2. Coordinate regulatory projects regarding the manufacturing transfer of acquired ANDA filings, including, but not limited to:o Manage project timelines and cross functional teams for supplements. o Review previous ANDA documentation for historical reference and current statuso Authoring eCTD documentation to compile supplements or providing authoring support.3. Manage annual ANDA filings:o Submit Annual and Periodic Reportso Prepare eCTD documentation in accordance with current eCTD structural guidelines 4. Assess change controls for regulatory impact of ANDA applications. Manage associated projects required for regulatory submissions.o Including CCS', API changes, USP updates5. Provide regulatory customer support for product launching.Skills:Regulatory, Chemistry, Biology, Documentation, Excel, Microsoft, ANDA, FDA, Submissions, eCTD, Change Control, APIs, USP updatesTop Skills Details:Regulatory,Chemistry,Biology,Documentation,Excel,Microsoft,ANDA,FDA,Submissions,eCTD,Change ControlAdditional Skills & Qualifications:MUST:Scientific Degree-1-2 years Pharma Regulatory Submission/FDA experience -ANDA filing experience -Change control experience BEST:-1 year lab or QA experience- 3-4 year+ experience in Regulatory Affairs (familiar with regulated environment)- Worked in an FDA/GMP regulated environment, not in the lab. About Actalent: Actalent connects passion with purpose. Our scalable talent solutions and services capabilities drive value and results and provide the expertise to help our customers achieve more. Every day, our experts around the globe are making an impact. We're supporting critical initiatives in engineering and sciences that advance how companies serve the world. Actalent promotes consultant care and engagement through experiences that enable continuous development. Our people are the difference. Actalent is an operating company of Allegis Group, the global leader in talent solutions. The company is an equal opportunity employer and will consider all applications without regards to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

Keywords: Actalent, Mount Prospect , Regulatory Affairs Senior Specialist, Other , Mount Prospect, Illinois