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Donna M Dea is listed as Regulatory Affairs Consultant at DeadOn Consulting, LLC, based in Landenberg, Pennsylvania, United States. AeroLeads shows a work email signal at astrazeneca.com and a matched LinkedIn profile for Donna M Dea.
Donna M Dea previously worked as Senior Director, Regulatory Affairs at Astrazeneca and Senior Director, Scientific and Medical Alliance at Astrazeneca. Donna M Dea holds Bachelor'S Degree, Biology, 4.0/4.0 from Saint Joseph'S University.
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Regulatory expert with extensive experience in the pharmaceutical industry. Highly skilled in designing and implementing regulatory strategies that deliver new medicines to patients or expand the use of approved products. Excellent coach for preparing teams for health authority interactions aimed at securing buy-in to the proposed regulatory and clinical strategy. Recognized as a critical reviewer of health authority submissions including NDAs/ MAAs and responses to health authority questions. Proficient in identifying gaps in “the story” and potential areas of concern for the health authorities that need to be addressed proactively. Strong strategic influencer able to present the agreed strategy to corporate stakeholders for their endorsement and health authorities for their acceptance. Personal strengths include: • Expertise in drug development regulations including combination products with a strong strategic thinking capability. • Works collaboratively and drives team performance. • Passionate about addressing the needs of patients, corporate stakeholders, and health authorities.
Listed skills include Regulatory Affairs, Drug Development, Regulatory Submissions, Pharmaceutical Industry, and 14 others.
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Currently providing consulting services for clients in the Pharmaceutical industry to support their regulatory affairs needs.
Wilmington, De
Global regulatory leader responsible for the development and implementation of global regulatory strategies supporting the approval of new treatments for asthma and COPD as well as the approval of new device platforms. Accountable for successful health authority interactions including those prior to the submission of the NDA/MAA and those during the review of the file.
Wilmington, De
Accountable for building and sustaining long-term, strategic relationships with leading universities and medical centers in US to help deliver the company’s R&D objectives. Represented AstraZeneca on the National Pharmaceutical Council (NPC) Advisory Group.
Wilmington, De
Global regulatory leader who as a member of the Senior Leadership Team assumed varying responsibilities over time including: • Leader of the Policy, Regulatory Intelligence and Labeling Group (2007-2008)• Leader of US Regulatory Managers, Documentation Specialists, and CMC Experts (2005-2007)• Regulatory Lead on the Key Brand Team for the development of a novel anticoagulant (2003-2005)• Regulatory Lead for the Respiratory & Inflammation Therapeutic Area (2002-2003)
Wilmington, De
Developed the overall US regulatory strategy for both current and future products in the respiratory and inflammation therapeutic area at AZ. Oversaw FDA interactions including the submission and negotiation of drug approvals and the preparation for FDA meetings.
Wilmington, De
Interfaced directly with FDA on all aspects of the development and marketing of a novel respiratory product (ACCOLATE) and two oncology products (NOLVADEX and ARIMIDEX).
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Donna M Dea works for DeadOn Consulting, LLC.
Donna M Dea is listed as Regulatory Affairs Consultant at DeadOn Consulting, LLC.
AeroLeads has found 1 work email signal at @astrazeneca.com for Donna M Dea at DeadOn Consulting, LLC.
Donna M Dea is based in Landenberg, Pennsylvania, United States while working with DeadOn Consulting, LLC.
Donna M Dea has worked for Deadon Consulting, Llc and Astrazeneca.
You can use AeroLeads to view verified contact signals for Donna M Dea at DeadOn Consulting, LLC, including work email, phone, and LinkedIn data when available.
Donna M Dea holds Bachelor'S Degree, Biology, 4.0/4.0 from Saint Joseph'S University.
Donna M Dea is listed with skills including Regulatory Affairs, Drug Development, Regulatory Submissions, Pharmaceutical Industry, Clinical Development, Respiratory Products, Fda, and Clinical Trials.
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