Principal Consultant in the Regulatory Practice of Lachman Consultants with 20+ years’ experience as a Regulatory professional in the pharmaceutical industry. With her expert knowledge of pharmaceutical regulations, standards, current industry practices, and strong practical experience, she delivers strategic leadership to Lachman’s clients, including for ANDA, NDA, and IND, [505(j), 505(b)(1) and 505(b)(2)] applications as well as throughout the entire project lifecycle: product feasibility, development, scale-up, submission, pending application management, approval / launch, post-approval changes, and compliance. Her expertise includes generic topical and extended-release injectable formulations and she has previous experience in solid oral dosage forms.
- Regulatory strategy development, review and operations; regulatory oversight during research and development phase
- Preparation, reviews, submissions of INDS, NDAs, ANDAs
- Regulatory submission oversight / review / preparation for adherence to current regulations, guidance, standards, and content requirements for eCTD submissions (controlled correspondence, meeting requests, briefing packages, original submissions, amendments, annual reports, safety reporting, supplements, and more)
- Evaluations of scientific reports, methodology, and data for consistency and accuracy throughout the application
- Annual reporting, fee payments, self-ID, product listing, and establishment registrations
- Acting as point person/main contact for interactions with FDA and international health authorities
- Due diligence audits
- Labeling reviews
- Standard Operating Procedure reviews
- Tolmar Inc.
- Vice President, Regulatory Affairs
- Senior Director, Regulatory Affairs
- Director, Regulatory Affairs
- Manager, Regulatory Affairs
- Consulting Services
- Geneva Pharmaceuticals
- Regulatory Associate
- Synergen, Inc.
- Research Associate / Regulatory Associate
- Regulatory Affairs Professional Society (RAPS)
- B.S. Microbiology – Colorado State University, Colorado