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Work Background
OncoBay ClinicalSenior Director, Regulatory Affairs
Jul. 2023
LumanityDirector of Regulatory Affairs
Feb. 2023 - Jul. 2023
ICON plcDirector of Regulatory Affairs
Aug. 2021 - Feb. 2023
ConfidentialSenior Director, Regulatory Affairs (Consultant)
Feb. 2021 - Aug. 2021Worked as a RA Snr Director in a consulting capacity Responsible for managing programs for the US as well as a team of consultants at one company Responsible for client deliverables and oversight as well as strategy
Pharmaron Clinical ServicesDirector of Regulatory Affairs
Aug. 2020 - Jan. 2021Washington DC-Baltimore Area
Served as a in-house Director of RA Consulting for a CRO specializing in clinical trials Responsible for client deliverables, proposals, and participating in bid defense meetings
Regulatory strategic advice and submission oversight
ConfidentialConsultant
Oct. 2019 - Jul. 2020Boston, Massachusetts, United StatesServed a a Consultant at two different companies for programs in Alzheimer’s and microbiome Oversight of submissions and strategy Program management
BioconGeneral Manager
Jan. 2019 - May. 2019Bengaluru, Karnataka, IndiaSkills: Team Leadership
BioconDirector of Regulatory Affairs
Oct. 2018 - Dec. 2018Washington DC-Baltimore Area
Caligor CoghlanDirector of Regulatory Affairs
Apr. 2018 - Aug. 2018Washington D.C. Metro Area
AstraZenecaAssociate Director, Global Regulatory Affairs
May. 2016 - Apr. 2018Global regulatory affairs Lead, manage and deliver high-quality regulatory submissions at all phases of clinical development.
Co-led and facilitated INDS and CTAS for CKD and HF in over 20 different countries in all regions of the globe.
Co-facilitated company wide cross-functional team to ensure submission timelines and regulatory issues were addressed in a timely manner.
Provided regulatory guidance and input into the requirements for a Type 1 DM pediatric program and reviewed submission/protocols for a Type 2 DM program. Contribute to regulatory subteam for HF and pediatrics.
Nominated as part of subteam for excellence in delivery of INDs/CTAs.
Ascent Services GroupRegulatory Affairs Consultant
Jan. 2016 - Apr. 2016Provided regulatory consulting services in the area of Regulatory research and intelligence to a top 15 Biopharmaceutical company in the Bay area.
LLOYDDirector of Regulatory Affairs
Sep. 2014 - Aug. 2015Greater Omaha AreaResponsible for regulatory submissions, regulatory strategy and compliance with a focus in development of generic applications in the area of thyroid disease.
CONRADDirector Regulatory Affairs
Jan. 2014 - Sep. 2014Responsible for all aspects of regulatory affairs including leading regulatory strategy, filing regulatory submissions and regulatory compliance for drugs and devices. Led the development of regulatory SOPs, regulatory documentation systems, overseeing the development of an FDA pilot submission, filing of two original IND applications, developing regulatory strategy for NDA, and device submissions.
George Washington UniversityAdjunct Faculty
Aug. 2013 - Dec. 2014Washington, DCAdjunct Faculty in the Clinical Leadership and Development Program
IpsenDirector, Regulatory Affairs
Jun. 2012 - Apr. 2013Director, Regulatory Affairs, Endocrinology: Demonstrated exceptional leadership of endocrinology therapeutic area, including portfolio of therapeutic products for treatment of growth disorders, endocrine tumors, and related gastrointestinal indications for U.S. and Canada. Supervise Regulatory Associate and Regulatory Contractor, perform role of key liaison to FDA, ensure compliance with regulatory reporting requirements, and lead FDA interactions, submissions, and meetings. Apply strategic and submission expertise to regional project teams and submission teams for NDA projects. Provide critical analysis and input into Regulatory Strategic Assessments for U.S. requirements. Ensure adequacy of regulatory strategies to address U.S. FDA requirements while providing alignment with EU strategy when possible. • Presented strategic insight and submission planning for 2 supplemental new drug applications in area of endocrine tumors at international project team meetings at EU headquarters.
• Alleviated potential shortage of drug for treatment of growth disorders through provision of effective regulatory strategy and filing of multiple submissions. • Oversaw completion of key submission for new syringe needle protection system.
Mitsubishi Tanabe Pharma Development AmericaSenior Manager
Aug. 2010 - May. 2012Senior Manager, Regulatory Affairs: Provided outstanding direction of NDA submission team for new chemical entity in area of kidney disease. Established framework for NDA submission, created ISS/ISE roadmaps, provided global regulatory strategy on pediatrics and expanded access, and authored and led IND transfer plan from third party to company. Headed preparation of pre-NDA briefing document, oversaw completion of nonclinical components by outside vendor for NDA submission, and drafted questions to FDA. Guided eCTD conversion of clinical study reports, provided regulatory input into review of key clinical documents, and developed Module 1 components of eCTD submission.
medicines360Senior Director, Regulatory Affairs
Oct. 2009 - Feb. 2010Senior Director, Regulatory Affairs: Participated in establishment of regulatory and compliance infrastructure, and formulated regulatory strategy in support of FDA meetings and IND submissions for early-stage development program.
Catalent Pharma SolutionsDirector, US Regulatory Consulting Services
Jun. 2008 - Oct. 2009Director, Regulatory Consulting: Trained and prepared clients for key regulatory meetings and filings with FDA in oncology, pain management, and inflammatory disease. Provided regulatory guidance to senior management, as well as feedback on SOPs for Regulatory Affairs staff. Performed role of regulatory liaison with FDA. • Supervised teams in FDA regulatory submissions, including 505(b)(2) NDA and 2 eCTD IND submissions.
• Facilitated revenue increase of nearly 100% by building new client networks, leading discussions on regulatory services, and writing client quotations.
• Authored regulatory affairs newsletter for U.S., Europe, and other countries to serve as educational tool while informing management of key legislative and regulatory changes.
Bayer HealthCareAssistant Director
Jun. 2007 - May. 2008Responsible for regulatory strategy, submissions, and compliance for assigned drug products.
Served as representative of GPT for US region and as primary liaison with FDA.
Led IND applications and Pre-IND meeting strategy.
Ensured regulatory compliance for assisted products.
Eisai Medical ResearchManager, Regulatory Affairs
Feb. 2006 - May. 2007Manager, Regulatory Affairs: Oversaw CNS therapeutic areas including Alzheimer’s, depression, epilepsy, and diabetic neuropathy. Provided input and review for global clinical development plans for management of U.S. and EMA requirements, applied regulatory expertise to international project teams, and managed post-approval submissions for regulatory compliance. Performed role of liaison with FDA for drug development projects. • Guided preparation and regulatory filing strategy of 2 IND submissions. • Presented on topic of FDA Critical Path as part of All-Employee Meeting Regulatory Panel.
FDARegulatory Health Project Manager
Dec. 1999 - Jan. 2006Regulatory Health Project Manager: Provided project management and initial regulatory reviews of IND and NDA submissions for adherence with PDUFA objectives, led completion of NDA approval packages, and provided post-lifecycle management of CMC, labeling, and Phase 4 commitments. • Facilitated approval of more than 10 NDA submissions in variety of therapeutic areas.
• Performed regulatory review and project management of hundreds of INDs.
• Earned 2 CDER Group Awards for project management.
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