Heather Manna Email & Phone Number
Vice President and Head of Global Regulatory Affairs and Advisory Board @ VMD Sciences
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Heather Manna Location
- Trenton, NJ, US
Heather Manna Work
- 2024 -now Vice President and Head of Global Regulatory Affairs and Advisory Board @
- 2022 -2025 Vice President Global Regulatory Affairs @
- 2021 -2022 Director of Regulatory Affairs @
- 2019 -2021 Director, US Head of Operations @
- 2018 -2019 Program Director @
- 2016 -2018 Associate Director, Expanded Access @
- 2014 -2016 Head of US Program Operations and US Regulatory Affairs @
- 2010 -2014 Senior Manager Regulatory Affairs @
- 2006 -2010 Senior Manager - Regulatory Operations, ImClone LLC A Wholly Owned Subisdiary of Eli Lilly and Co. @ ImClone Systems, Corporation
- 2005 -2006 Global Dossier Lead - Manager, Regulatory Operations @ Sanofi-Aventis Pharmaceuticals (formerly Aventis Pharmaceuticals)
- 2002 -2005 Global Regulatory Coordinator, Manager, Regulatory Affairs @ Sanofi-Aventis Pharmaceuticals
- 2000 -2002 Global Project Planner - Senior Specialist, Project Management @
- 2000 -2000 Regulatory Quality Control Specialist @ PRA International, Inc
- 1999 -2000 Regulatory Affairs Consultant @ TEVA Pharmaceuticals USA
- 1997 -1999 Regulatory Affairs Coordinator @ Takeda America Research & Development Center, Inc
- 1994 -1997 Aministrative @
Heather Manna Education
- West Windsor Plainsboro High School 1982-1988
- University of Phoenix
Coursework, BS Business Management
- University of Phoenix
- Thomas Edison State University
Coursework (Business Administration and Liberal Arts)
- Villanova University
Heather Manna Skills
- Regulatory Submissions
- Regulatory Affairs
- Clinical Trials
- IND
- Oncology
- Regulatory Requirements
- FDA
- eCTD
- GCP
- Sop
- Pharmacovigilance
- Project Planning
- Project Management
- CRO
- Pharmaceutical Industry
- Biotechnology
- Clinical Development
- Therapeutic Areas
- Pharmaceutics
- Medical Writing
- 21 CFR Part 11
- GMP
- Drug Safety
- CMC
- 21 CFR Part 50, 56, 312, 314, 600
- Expanded Access Porgrams
- Regulatory Strategy
- Writing
- Drug Development
- Biopharmaceuticals
- Lifesciences
- GLP
- Clinical Operations
- Protocol
- Medical Devices
- GxP
- ICH-GCP
- Code of Federal Regulations
- NDA
- BLA
- CTA
- MAA
- Life Sciences
- Standard Operating Procedure (SOP)
- Expanded Access Programs
- U.S. Food and Drug Administration (FDA)
- Expanded Access
- Ich Gcp
- Public Speaking
- Regulatory
- 21 Cfr Part 50
- Quality Assurance
- Operations
- Standard Operating Procedure Sop
- u.s. Food and Drug Administration Fda
- Standard Operating Procedure
- u.s. Food and Drug Administration
Heather Manna Summary
- Heather Manna, based in Trenton, NJ, US, is currently a Vice President and Head of Global Regulatory Affairs and Advisory Board at VMD Sciences. Heather Manna brings experience from previous roles at Inceptua Group, RealiTi Health, myTomorrows and Expanded Access Summit. Heather Manna holds a 1982 - 1988 West Windsor Plainsboro High School. With a robust skill set that includes Regulatory Submissions, Regulatory Affairs, Clinical Trials, IND, Oncology and more. Heather Manna has 3 emails and 6 mobile phone numbers on RocketReach.
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