Robert Cormack
Scientific Regulatory Affairs Lead at Capricor Therapeutics, Inc. | Los Angeles, California, United States
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Robert Cormack serves as the Scientific Regulatory Affairs Lead at Capricor Therapeutics, Inc., where he leverages over 20 years of extensive experience in regulatory affairs and drug development. With a PhD in Biochemistry and certifications in Regulatory Affairs (RAC) and Certified Associate in Project Management (CAPM), Robert is uniquely positioned to navigate the complexities of the pharmaceutical landscape. His role involves overseeing the regulatory strategy for innovative therapies, particularly in the fields of oncology and biotechnology, ensuring compliance with U.S. Food and Drug Administration (FDA) guidelines throughout all phases of drug development, from Investigational New Drug (IND) applications to post-approval activities.
At Capricor, Robert is currently spearheading key projects aimed at advancing the company’s pipeline of regenerative medicine products. His expertise in Good Clinical Practice (GCP) and familiarity with both innovative and generic drug environments enable him to effectively collaborate with cross-functional teams, including clinical operations and quality assurance, to streamline regulatory submissions and enhance the likelihood of successful outcomes. Robert’s strategic planning skills and independent, self-starter mentality allow him to anticipate regulatory challenges and devise proactive solutions that align with the company’s goals.
His deep understanding of regulatory precedents and procedures not only aids in navigating the complexities of the FDA’s regulatory framework but also positions Capricor as a leader in the biotechnology sector. As a trusted advisor, Robert plays a crucial role in shaping the company’s regulatory strategy, ensuring that Capricor’s innovative therapies can reach patients in need while maintaining the highest standards of safety and efficacy.
Scientific Regulatory Affairs Lead at Capricor Therapeutics, Inc. in March 2024 to Present
Principal Consultant at NDA Group AB in July 2021 to February 2024
Senior Director of Regulatory Affairs at Capricor Therapeutics, Inc. in May 2020 to July 2021
Director of Regulatory Affairs at Pacific-Link Consulting in September 2018 to April 2020
Regulatory Affairs Consultant at Independent Contractor in June 2017 to September 2018
Senior Director of Regulatory Affairs at Amphastar Pharmaceuticals, Inc. in June 2016 to May 2017
Director of Regulatory Affairs at ICON plc in December 2011 to June 2015
Director of Regulatory Affairs at Sucampo Pharmaceuticals, Inc. in June 2005 to November 2011
Regulatory Affairs Specialist at Human Genome Sciences in September 2003 to May 2005
Regulatory Affairs Specialist at PSI International in January 2000 to September 2003
Staff Scientist at OriGene Technologies in August 1998 to December 1999
Post-Doctoral Fellow at MPIPZ - Max Planck Institute for Plant Breeding Research in June 1994 to August 1998
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IND
Regulatory Affairs
Regulatory Submissions
Clinical Development
Clinical Trials
Pharmaceutical Industry
CRO
GCP
Biotechnology
FDA
Regulatory Requirements
Oncology
Biopharmaceuticals
Pharmacovigilance
SOP
U.S. Food and Drug Administration (FDA)
Drug Development
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Discover more about Capricor Therapeutics, Inc.What is Robert Cormack email address?
Email Robert Cormack at [email protected] and [email protected]. This email is the most updated Robert Cormack email found in 2026.
What is Robert Cormack phone number?
Robert Cormack phone number is +13018616839 and +12028616839.
How to contact Robert Cormack?
To contact Robert Cormack send an email to [email protected] or [email protected]. If you want to call Robert Cormack try calling on +13018616839 and +12028616839. (updated on October 29, 2024)
What company does Robert Cormack work for?
Robert Cormack works for Capricor Therapeutics, Inc.
What is Robert Cormack's role at Capricor Therapeutics, Inc.?
Robert Cormack is Scientific Regulatory Affairs Lead
What industry does Robert Cormack work in?
Robert Cormack works in the Biotechnology Research industry.
Robert Cormack Email Addresses
Robert Cormack Phone Numbers
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