Ellen is an accomplished regulatory executive with over 20 years of diversified experience in the pharmaceutical industry including leadership, drug development, creative regulatory solutions, and preparation of high-quality submissions. She has cultivated a talent in navigating current regulations, identification of regulatory trends and surveillance of FDA initiatives to leverage regulatory opportunities for creative market entrances and regulatory pathways.
Key areas of expertise
- Regulatory leader with a deep understanding of the pharmaceutical industry and delivery of thought leadership on client projects.
- Proficiency in identification of regulatory risk identification and mitigation strategies to ensure a successful outcome.
- Tenured knowledge in generic drug regulations with management of numerous ANDAs and FDA responses, including successful navigation of complex regulatory challenges.
- Experience with NDAs, including 505(b)(2) pathways, pre-IND communications, IND submissions, and lifecycle management for ANDAs and NDAs.
- Successful engagement and oversight of various regulatory disciplines, including CMC, labelling, bioequivalence strategies, pharmacovigilance, and post approval regulatory activities for both ANDAs and NDAs.
- Extensive experience in various small molecule drug products, including immediate and modified release oral (solids and liquids), semi-solid topical (creams and ointments), and rectal dosage forms; familiarity with drug-device combination products.
- Well versed in due diligence and regulatory strategy of potential product acquisitions, license deals, and evaluation of unique potential opportunities for viability.
- Experience engaging the FDA in therapeutic areas of cardiology, neurology, endocrinology, and gastroenterology.
Before joining NDA, Ellen was the Vice President of Regulatory Affairs at ANI Pharmaceuticals, Inc. As a member of the executive leadership team, she contributed to successful expansion of the company’s size and hybrid product portfolio to over 250+ drug applications, consisting of both ANDAs and NDAs of various dosage forms.
As part of this rapid growth, she was responsible for creating and implementing systems and identifying resource requirements to align with business needs to ensure compliant support of regulatory and pharmacovigilance. Ellen lead the team and regulatory strategy for pipeline products and oversaw various regulatory disciplines, including CMC, labeling, and life-cycle management submissions across all drug applications.
During her tenure at ANI Pharmaceuticals, Inc. she became well versed in due diligence and regulatory strategy of potential product acquisitions, license deals, and evaluation of unique potential opportunities for viability.
Early career positions at Sandoz (and its legacy company Eon Labs) were held in both regulatory affairs and analytical research and development creating experience in method development, method validation, and drug development concepts in regulated environments.