Associate Director of Regulatory Affairs
RiconPharma LLC
Denville, NJ
Apply
JOB DETAILS
SALARY
$179,296–$182,296 Per Year
JOB TYPE
Full-time, Employee
SKILLS
Abbreviated New Drug Application, Biotech and Pharmaceutical, Candidate Sourcing, Change Control, Chemistry, Dosage Forms, Drug Products, Electronic Publishing, FDA Requirements, ICH Regulations, Marketing Authorization Application (MAA), New Drug Application, Pharmacy, Regulations, Regulatory Submissions, Technical Writing
LOCATION
Denville, NJ
POSTED
10 days ago
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 hr@ingenus.com Job Number: 32026
About the Company
R
RiconPharma LLC
INDUSTRY
Biotechnology/Pharmaceuticals