Senior Regulatory Submission Management with over eight years experience focused in coordinating, managing and compiling submissions; New IND, NDA, BLA, sNDA/sBLA, ANDA, OPDP and CPP. Exceptional relationship management and influencing skills to drive complex regulatory submissions while working cross-functionally and collaboratively across stakeholders and regulatory agency. Compilation of submissions from pre-clinical to clinical in Modules 1-5 and managing dossiers for submissions to the global regulatory agency.
Results-focused team player with specialty in electronic/eCTD submissions. Reputation for excelling at improving process, strong technical aptitude, meeting tight timelines without sacrificing quality and establishing solid relationships with regulatory agency and counterparts. Successful background in a fast-paced organization with daily deadlines. Ability to obtain deep knowledge and teamwork skills and foundation to be a successful leader and high quality solutions provider.
Specialties: New IND Submission, IND Amendment, Global Submit, Drug Safety, OPDP, IP (Investigators Package), CPP (Certificate of Pharmaceutical Product), Regulatory Project Management, InSight Publisher, Clinical Trial and eCTD. Knowledge of GMP’s, GCPs, GLP’s, Industry Guidance’s, ICH guidelines, SOP’s, and 21 CFR.
Software: eCTD XPress, Liquent InSight Publisher, Global Submit 2010, Core Dossier (application), RAPID (firstdoc/documentum), ISI Toolkit, Adobe, A4L, SPL, MS Office, and GPRS (Global Product Regulatory System)
Accomplishment: Successfully prepared and submitted seven New IND Submissions for several therapeutics areas such as; Advanced Malignancies Leukemia, (AML), Autism Spectrum Disorder (ASD), Age-related macular degeneration (AML), Chronic Lymphocytic Leukemia (CLL), Schizophrenia, Alzheimer's disease and Spinal Muscular Atrophy syndrom. This achievement was recognized by head of global regulatory of Roche.