Associate Director of Regulatory Affairs

Job responsibilities: Develop and execute comprehensive regulatory strategies for ANDA/ NDA submissions, ensuring alignment with FDA requirements under 505(j)/ 505(b)(2) pathways. Lead preparation, review of regulatory submissions to US FDA in a dynamic and fast-paced environment. Devise strategy and draft/review Controlled Correspondences and Meeting Packages like Pre-IND, ANDA Product Development, Enhanced Mid Cycle Review and Post CRL with limited supervision. Develop responses to FDA queries (Filing review, IRs, DRLs, and CRLs) and ensure timely submission of amendments and supplements. Manage post-approval CMC activities, including the preparation and submission of supplements (CBE-0, CBE-30, PAS) and annual reports. Provide regulatory oversight for CMC-related updates, review, and provide change control assessments as required. Provide regulatory guidance to cross-functional teams on product development, manufacturing, testing, and commercialization of various complex drug products and dosage forms. Establish and maintain effective internal and cross-functional team communications, i.e., provide regular feedback and communicate work challenges/issues and successes. Oversee development and review of product labeling, including prescribing information, carton/container labeling, and patient information leaflets, ensuring compliance with FDA regulations (21 CFR Part 201), PLR/PLLR formatting requirements, and all applicable labeling guidance’s. Oversee the end-to-end preparation, compilation, and lifecycle management of regulatory submissions in Electronic Common Technical Document (eCTD) format, ensuring full compliance with FDA eCTD Technical Conformance Guide and regional specifications. Ensure submission content across Modules 1 through 5 adheres to formatting and technical requirements, including correct use of metadata and compliance with Study Tagging File (STF) standards for clinical and nonclinical study data. Independently submit eCTD submissions via the FDA ESG NextGen portal, including access and user role administration.Requirements: Applicant must have a Master’s degree (or US Equivalent) in Pharmaceutical Regulatory Affairs, Pharmacy, Chemistry or related field. Three (3) years’ experience in regulatory affairs with a focus on USFDA and complex generics. Experience in compiling high-quality marketing authorization applications (505 (b)(2) NDAs and ANDAs). Experience in overseeing labelling and publishing eCTD product dossier compilation. Extensive knowledge of U.S. regulatory frameworks, including FDA regulations and ICH guidelines. Hands-on work experience on eCTD Modules 1, 2, 3, and 5. Hands on experience end-to-end preparation, compilation, and lifecycle management of regulatory submissions in Electronic Common Technical Document (eCTD) format. Experience in post-approval CMC activities, including the preparation and submission of supplements (CBE-0, CBE-30, PAS) and annual reports. Must have experience with the following: Electronic publishing, structured product labeling, change controls, establishment registrations, and self-identifications. Applicants must have expertise across a diverse dosage form including solid orals, injectables and drug device combination products. 40 hours per week, M-F, 9am - 5pm. Must have proof of legal authority to working the United States. $179,296.00 to $182,296.00 per year. To be considered, please visit RiconPharma LLC’s, an Ingenus Pharmaceuticals affiliate, career site website at https://www.ingenus.com/careers/ and apply by emailing your resume to Job Number: 32026