Donna M Dea

Donna M Dea Email and Phone Number

Regulatory Affairs Consultant @
Donna M Dea's Location
Landenberg, Pennsylvania, United States, United States
Donna M Dea's Contact Details

Donna M Dea work email

Donna M Dea personal email

n/a
About Donna M Dea

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.

Donna M Dea's Current Company Details
DeadOn Consulting, LLC

Deadon Consulting, Llc

Regulatory Affairs Consultant
Donna M Dea Work Experience Details
  • Deadon Consulting, Llc
    Regulatory Affairs Consultant
    Deadon Consulting, Llc 2015 - Present
    Currently providing consulting services for clients in the Pharmaceutical industry to support their regulatory affairs needs.
  • Astrazeneca
    Senior Director, Regulatory Affairs
    Astrazeneca 2010 - 2014
    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.
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  • Astrazeneca
    Senior Director, Scientific And Medical Alliance
    Astrazeneca 2008 - 2010
    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.
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  • Astrazeneca
    Vice President, Regulatory Affairs
    Astrazeneca 2002 - 2008
    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)
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  • Astrazeneca
    Executive Director, Regulatory Affairs
    Astrazeneca 1999 - 2002
    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.
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  • Astrazeneca
    Manager, Regulatory Affairs
    Astrazeneca 1996 - 1999
    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 Skills

Regulatory Affairs Drug Development Regulatory Submissions Pharmaceutical Industry Clinical Development Respiratory Products Fda Clinical Trials Pharmacovigilance Oncology Gcp Drug Safety Team Leadership People Development Regulatory Requirements Pharmaceutics Biotechnology Life Sciences

Donna M Dea Education Details

Frequently Asked Questions about Donna M Dea

What company does Donna M Dea work for?

Donna M Dea works for Deadon Consulting, Llc

What is Donna M Dea's role at the current company?

Donna M Dea's current role is Regulatory Affairs Consultant.

What is Donna M Dea's email address?

Donna M Dea's email address is do****@****eca.com

What schools did Donna M Dea attend?

Donna M Dea attended Saint Joseph's University.

What are some of Donna M Dea's interests?

Donna M Dea has interest in Social Services.

What skills is Donna M Dea known for?

Donna M Dea has skills like Regulatory Affairs, Drug Development, Regulatory Submissions, Pharmaceutical Industry, Clinical Development, Respiratory Products, Fda, Clinical Trials, Pharmacovigilance, Oncology, Gcp, Drug Safety.

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