Ed Porter
Vice President Medical and Regulatory at Curium Pharma | Greater St. Louis
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Ed Porter serves as the Vice President of Medical and Regulatory Affairs at Curium Pharma, where he plays a pivotal role in shaping the strategic direction for new product development and lifecycle management. With extensive experience in regulatory affairs, Ed is adept at navigating complex regulatory landscapes, ensuring compliance with health authority requirements across various regions. His expertise encompasses a wide array of regulatory submissions, including IND, MAA, NDA, ANDA, DMF, and ASMF, which are critical for the successful introduction of new chemical entities (NCEs) and line extensions.
At Curium Pharma, Ed leads key initiatives that support clinical programs and product geographic expansions, focusing on both solid oral and aseptic formulations. His strategic oversight extends to the development of regulatory strategies that align with the company’s goals for innovation and market access. Ed's commitment to quality and safety is evident in his collaboration with health authorities, where he leverages his global experience to foster productive relationships that facilitate timely approvals.
In addition to his regulatory acumen, Ed is well-versed in quality management systems, including GMP and ISO 13485, which are essential for ensuring that products meet the highest standards of safety and efficacy. His proficiency in clinical research and understanding of 21 CFR Part 11 regulations further enhance his ability to guide teams through the complexities of clinical development and investigation. With a strong focus on regulatory operations, Ed Porter is dedicated to advancing Curium Pharma’s mission to deliver innovative healthcare solutions while maintaining the highest levels of compliance and operational excellence.
Vice President Medical and Regulatory at Curium Pharma in January 2022 to Present
Vice President of Compliance at Curium Pharma in November 2018 to January 2022
Sr. Director Compliance - Quality and Regulatory Affairs at Curium Pharma in July 2017 to November 2018
Regulatory Affairs Director at Curium Pharma in January 2015 to June 2017
Director International Regulatory Affairs at Mallinckrodt Pharmaceuticals in January 2010 to January 2017
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Pharmaceutical Industry
FDA
Regulatory Submissions
Regulatory Affairs
V&V
Medical Devices
CAPA
Validation
Biotechnology
Sop
GMP
ISO 13485
Clinical Trials
Change Control
HPLC
Clinical Research
Medical Affairs
Clinical Development
21 CFR Part 11
Regulatory Requirements
SOP
Verification and Validation (V&V)
GLP
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Discover more about Curium PharmaWhat is Ed Porter email address?
Email Ed Porter at [email protected]. This email is the most updated Ed Porter email found in 2026.
What is Ed Porter phone number?
Ed Porter phone number is +13146605234 and +13145950934.
How to contact Ed Porter?
To contact Ed Porter send an email to [email protected]. If you want to call Ed Porter try calling on +13146605234 and +13145950934. (updated on October 24, 2024)
What company does Ed Porter work for?
Ed Porter works for Curium Pharma
What is Ed Porter's role at Curium Pharma?
Ed Porter is Vice President Medical and Regulatory
Ed Porter Email Addresses
Ed Porter Phone Numbers
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