Job Description – Regulatory Affairs Manager – New Drug Applications (NDA), Small Molecules
Reports To: Head, Strategic operations, and Regulatory Affairs
Prepare and Review compilation of regulatory submissions like IND, NDA, responses to FDA queries, supplements, Meeting Packages and Proprietary Name requests with limited supervision.Provide regulatory guidance to cross functional teams on product development, manufacturing, testing and commercialization of various complex drug products and dosage forms.Stay current and proactively implement new regulations published by the US FDAEstablish and maintain effective internal and cross-functional team communications i.e. provide regular feedback and communicate work challenges/issues and successes.Identify technical gaps in the New and Filed applications and inform the Management/supervisor.Review and approve commercial labeling and complete drug listing for commercial products.Provide change control assessment and appropriate regulatory classification for post-approval changes proposed by the cross-functional teams.Maintenance of Electronic Submissions Gateway account and eCTD softwareTrain and educate other associates as needed.Any other work assigned by the supervisor.Requirements and Qualifications:
Bachelor's degree with 5 plus years' experience in regulatory strategy and filing of New Drug Applications (NDA) in a pharmaceutical Industry.Hands on experience of using any e-CTD build software.Ability to multi-task in a fast-paced environment with minimal supervision.Ability to work flexibly, organize own workload and effectively manage competing priorities.Excellent attention to detail and accuracy maintaining consistently high-quality standards.Ability to establish and maintain effective working relationships with coworkers, managers and clients.Willingness to learn new skills and flexibility to support business needs.Apply knowledge and expertise, to contribute to and provide solutions to process improvements. Upload Resume | Portfolio File types (doc, docx, pdf, rtf, png, jpeg, jpg, bmp, jng, ppt, pptx, csv, gif) size up to 5MB#J-18808-Ljbffr
