Dawn Rubel

VP Of Quality And Regulatory Affairs, Nice-Pak/PDI

Dawn Rubel is a Vice President, Quality and Regulatory Affairs at Nice-Pak/ PDI.  In this role, her responsibility spans across two affiliated ISO-Certified companies and includes products regulated by FDA (Rx and OTC drug, medical device) and EPA as well as cosmetic, consumer, and food safety products.  Ms. Rubel specializes in Quality, Compliance, and Regulatory Affairs for the Biotechnology and Pharmaceutical industries. She is currently responsible for managing the following Corporate functions for the Enterprise and three manufacturing sites in North America:

1. Quality Assurance
2. Regulatory Affairs
3. Regulatory Compliance
4. Quality Control (Analytical and Microbiology)
5. Validation
6. Environmental Health and Safety (EHS)
7. Training

She is also the Chair of the Corporate Quality Council and the primary contact for Regulatory Authority and third-party inspections.
Ms. Rubel joined Nice-Pak/ PDI as Vice President, Quality in November 2013 and was promoted to Vice President, Quality and Regulatory Affairs in June, 2015.  From April 2007 through November 2013, she held progressively responsible positions (most recently Vice President, Quality) at Immunomedics, Inc., a New Jersey-based biopharmaceutical company primarily focused on the development of monoclonal antibody-based products for the targeted treatment of cancer, autoimmune and other serious diseases.  Prior to that, Ms. Rubel was Director of Quality at Sentrx, a clinical pharmacovigilance company.  Before that, Ms. Rubel held positions of increasing leadership in Quality, Manufacturing, and Research & Development with Wyeth Biotech/ Wyeth Pharmaceuticals (now Pfizer). 
Ms. Rubel received an MBA with honors from Fairleigh Dickinson University, has completed graduate courses in Pharmaceutics at Long Island University, and earned a BA in Biology summa cum laude from Caldwell University.

Ms. Rubel has expertise in transformational compliance, including gap remediation and risk management.  She develops and implements best practices for sustainable compliance, product manufacturing, and quality management; develops optimized Regulatory pathways, and evaluates new technologies for implementation of streamlined, controlled and compliant systems.  She has led Global teams responsible for technical transfer and implementation of validated Enterprise solutions.  Ms. Rubel has been a conference speaker on Quality topics and has consulted on Organization building, GMP transformations, Technology, Quality, Inspection Readiness, Compliance and Validation for a variety of regulated industries. 

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Wednesday 2:00 pm - 3:30 pm
Staying Ahead of Environmental Hot Spots

Navigating “Deregulation” in the Regulated Environment

This presentation will address the current political promise of deregulation in the U.S. EPA and FDA. It will examine potential short, mid, and long-term impact for business in the Regulated Environment, and share strategies for navigating exchanges with Regulatory Agencies during this time.