Dawn Cleaver

Dawn Cleaver Email and Phone Number

Associate Director, Regulatory Affairs at Zoetis @ Zoetis
parsippany, new jersey, united states
Dawn Cleaver's Location
Kalamazoo, Michigan, United States, United States
Dawn Cleaver's Contact Details

Dawn Cleaver personal email

About Dawn Cleaver

Licensed veterinarian with 25+ years of experience.13 years of general veterinary practice experience.13+ years of experience in the animal health industry; 12+ years in pharmaceutical regulatory affairs.- Build and maintain professional relationships with regulatory officials; represent organization during communications with the Center for Veterinary Medicine, Food and Drug Administration for product registrations and broader regulatory issues. Represent organization at various Animal Health Institute working groups or workshops.- Regulatory lead on project teams from discovery through approval providing direction on studies required for product approval.- Prepare team for meeting with CVM to discuss project progression.- Prepare New Animal Drug Applications.- Lead team in response to any agency queries.- Through discussions with the agency develop appropriate product labeling.- Participate in transfer of product knowledge to commercial team.- Provide strategic regulatory guidance on life-cycle management of approved products.- Lead Labeling team for all FDA regulated products; submit all updated product labeling and drug experience reports.

Dawn Cleaver's Current Company Details
Zoetis

Zoetis

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Associate Director, Regulatory Affairs at Zoetis
parsippany, new jersey, united states
Website:
zoetis.com
Employees:
7922
Dawn Cleaver Work Experience Details
  • Zoetis
    Associate Director, Regulatory Affairs
    Zoetis Nov 2003 - Present
    Kalamazoo, Michigan Area
    Successfully prosecute registration of New Animal Drug Applications (NADAs) through FDA/CVM.-Have an excellent understanding of the 21 CFR for new animal drug applications, and the ability to interpret regulations and to leverage them into favorable strategies for drug registration and appropriate drug Labeling. - Build and maintain professional relationships with regulatory officials for the purpose of receiving clear guidance on preparation of new animal drug applications.- Lead multi-disciplinary teams in creation of global development programs for new chemical entities and life-cycle extensions. - Provide regulatory leadership across the organization on current CVM policies/procedures.- Prepare teams for discussions with agency, submissions of new animal drug applications and any additional queries.- Provide approved product support as needed.Lead Labeling & Drug Experience Regulatory Team.- Team is responsible for submissions of all final printed labels to the agency for review and approval.- Team is responsible for submission of all drug experience reports for FDA regulated products as well as antimicrobial reports.
  • Pfizer Animal Health
    Pharmaceutical Clinical Development, Manager
    Pfizer Animal Health Apr 2002 - Oct 2003
    Groton Ct
    Monitor/ Conduct studies for pharmaceutical developmentWrite protocolsVerify dataWrite study reports Assist in submissions to CVM
  • Banfield Pet Hospital
    Veterinarian
    Banfield Pet Hospital 1998 - 2001
    Greater Denver Area
    Lead Doctor at Pecos Clinic: supervision of lay staff and technicians, responsible for the operation and production of the hospital. Staff veterinarian at Quincy and Westminster locations.

Dawn Cleaver Skills

Regulatory Affairs Regulatory Submissions Clinical Development Pharmaceutical Industry Fda

Dawn Cleaver Education Details

Frequently Asked Questions about Dawn Cleaver

What company does Dawn Cleaver work for?

Dawn Cleaver works for Zoetis

What is Dawn Cleaver's role at the current company?

Dawn Cleaver's current role is Associate Director, Regulatory Affairs at Zoetis.

What is Dawn Cleaver's email address?

Dawn Cleaver's email address is dn****@****ail.com

What schools did Dawn Cleaver attend?

Dawn Cleaver attended University Of Florida College Of Veterinary Medicine, Mount Holyoke College.

What skills is Dawn Cleaver known for?

Dawn Cleaver has skills like Regulatory Affairs, Regulatory Submissions, Clinical Development, Pharmaceutical Industry, Fda.

Who are Dawn Cleaver's colleagues?

Dawn Cleaver's colleagues are Elva Valencia, Jack Bauman, Pa{Ul Galarza Zárate, Atkarut Kosit, Sheharyar Baig, Bec Mussared, Derrick Harris.

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