Associate Director of Regulatory Affairs–Denville, NJ

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.

Qualifications and Experience:

• 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 hr@ingenus.com. Job Number: 32026