Extensive regulatory affairs' experience in the pharmaceutical Rx drug industry in leadership and hands-on roles in the areas of: PML (Product Life-Cycle Management) of Rx drugs. Resulted in the submission / maintenance of many INDs, NDAs and ANDAs and 1 BLA, including INDs and changes to product labeling, CMC and efficacy information. IND / NDA / ANDA data and text documents / sections. Clinical regulatory affairs documents / data including, in concert with the statistician, a review of SAPs. Review human Rx drug promotional labeling / package inserts. Review drug product batch records for consistency. Submitted NDAs, ANDAs and original INDs that met FDA's regulations and company objectives within budget and established timeframes. Applied to Rx drug products with the following administration routes: oral (tablets/capsules, liquids/suspensions), intravenous, ophthalmic and topical). Reviewed/approved all change control requests from a US regulatory perspective of a botulinum Type B parenteral for 4 years, categorizing changes requiring supplements as CBEs, CBE-30s and PASs. Highly motivated with successful implementation of regulatory tactical objectives by effective communication with the FDA and across several company functional units (e.g., QA/QC, R&D, Clinical) Well-versed in the following therapeutic areas: central nervous system (CNS), anti-infective, antihypertensive, cardio-renal, gastro-intestinal, endocrine, and anti-inflammatory/analgesic. Extensive experience in preparing amendments/supplements to a BLA (a botulinum toxin, Type B injectable biologic product). Thorough knowledge of FDA and ICH regulations in Rx drug development. Liaised with FDA relating to INDs, NDAs ANDAs and BLAs. Proven track record in developing strategic labeling and promotional materials that resulted in successful product launches. Reviewed and was the regulatory signatory for hundreds of promotional pieces involving direct interactions with the ad agencies/Marketing/Sales/Medical Affairs with all pharmaceutical companies in which I was employed. Developed the labeling for several Rx drug products. Directly interacted with OPDP (aka, DDMAC) relating to promotional materials for Rx drug products.