James B. Davis
Chester,NJ
Summary
I am a pharmaceutical and biotech professional with over 21 years of experience in Global Regulatory Affairs Strategy. I have experience from Phase 1 through post-marketing in multiple therapeutics areas and modalities including: oncology, cardiovascular, type 2 diabetes, dermatology, ophthalmology, immunology, orphan diseases, combination drug development, biologics and NMEs, and use of real world evidence (RWE) for indication seeking purposes. I have led two NMEs to first-cycle FDA approvals. I am self-motivated and solutions driven with demonstrated interpersonal and leadership skills. Proven ability to efficiently and effectively manage multiple projects while maintaining a high level of detail orientation.
Overview
27
27
years of professional experience
1
1
Certification
Work History
Senior Director, Global Regulatory Affairs
Rocket Pharmaceuticals, Inc
06.2024 - Current
- Co-led the preparation and submission of biological license application (BLA) for Rocket Pharmaceuticals lentiviral asset, FANSKYA for the treatment of Fanconi Anemia on 02 August 2024.
- Led planning, writing, and reviewing of critical regulatory documents to support BLA submission.
- Led major submissions and meeting briefing packages.
- Provide global regulatory strategic input, including interpretation of guidelines relevant to the development of gene-therapy agents.
Senior Director, Global Regulatory Affairs, Oncology
Erasca Inc
06.2021 - 05.2024
- Develop and implement US and EU regulatory strategies for projects in different stages of development (Phase I through Registration) for clinical-stage precision oncology company.
- Serve as a primary liaison to US FDA, EMA, and other key market health authorities for assigned projects.
- Led submissions of INDs, major submissions, and meeting briefing packages.
- Define appropriate regulatory strategies, coordinate the execution of regulatory submissions including, but not limited to clinical trial applications, Investigational Drug (IND/IMPD) applications, marketing applications etc.
- Maintain awareness of developing views/guidance within FDA and EMA on general and specific topics related to the therapeutic area and other development projects as appropriate.
- Worked with local Regulatory partners, oversaw interactions and CTA filings with health authorities worldwide.
Executive Director, Regulatory Affairs, Oncology
Hookipa Pharma
12.2020 - 06.2021
- Develop and implement US regulatory strategies for projects in different stages of development (Phase I through Registration) for biopharmaceutical company developing a new class of immune-therapeutics, targeting infectious diseases and cancers based on its proprietary arenavirus platform that is designed to reprogram the body’s immune system.
- Serve as a primary liaison to US FDA, EMA, and other key market health authorities for assigned projects.
- Define appropriate regulatory strategies, coordinate the execution of regulatory submissions including, but not limited to clinical trial applications, Investigational Drug (IND/IMPD) applications, marketing applications etc.
- Maintain awareness of developing views/guidance within FDA and EMA on general and specific topics related to the therapeutic area and other development projects as appropriate.
Deputy Director Regulatory Affairs, Oncology
Bayer Pharmaceuticals
02.2017 - 12.2020
- Provide Global regulatory strategic input, including interpretation of guidelines relevant to the development and maintenance of assigned oncology project(s) to multi-functional global teams and external partners.
- Review key preclinical and clinical documents advising teams on risks and de-risking strategies.
- Prepare regulatory submissions (meeting briefing packages, responses to questions, post-marketing commitments, new protocol submissions, orphan drug applications, fast track applications)
- Led and organized FDA meetings (Pre-IND, Pre-NDA, Breakthrough Designation, Real-Time Oncology Review, Type C Developmental Meetings)
- Led regulatory collaborations with Merck and BMS with their respective immune checkpoint inhibitors with Bayer’s tyrosine kinase inhibitor, regorafenib.
Associate Director DRA Global Project Leader, Regulatory Affairs
Actelion Clinical Research
02.2013 - 02.2017
- Managed and successfully led US regulatory activities supporting FDA’s NDA review and approval process for Actelion’s NME, UPTRAVI (selexipag) (FDA approved on 12/21/2015).
- Led multiple FDA meetings, which included the preparation activities for internal personnel attending.
- Led NDA submission planning activities to allow for NDA successful submission 4Q2014.
Senior Manager, Regulatory Affairs
Celgene Corporation
01.2009 - 02.2013
- Managed U.S. regulatory strategic thinking, technical regulatory activities, and proactive communication to influence multi-functional global teams for oncology products, including liaison with external partners.
- Coordinated the preparation and submission of required documents to regulatory agencies that are complete and properly formatted, and comply with applicable regulatory regulations.
- Interacted with FDA on all aspects of product development.
Senior Program Manager, Regulatory Affairs
Hoffman-La Roche
03.2007 - 11.2008
- Served as U.S. Regulatory lead on global development teams in Roche’s metabolic therapeutic area.
- Led interactions, negotiations, and meetings with FDA as primary FDA liaison.
- Provided regulatory input into clinical development plans.
- Evaluated adequacy of preclinical data to support early stage clinical trials.
- Managed IND/NDA maintenance activities, including preparation of annual reports, protocol and information amendments, and FDA meeting packages.
- Coordinated and submitted INDs.
Senior Manager, Regulatory Affairs
OSI (Eyetech) Pharmaceuticals
07.2006 - 03.2007
- Served as primary regulatory lead for ophthalmic product, Macugen for wet AMD.
- Acted as primary liaison for the Division of Anti-Infective and Opthalmology Products at the FDA.
- Provided U.S. regulatory input and risk assessment for clinical development plans and clinical research strategies.
- Led negotiations with FDA to revise previously agreed upon post-approval commitments.
- Coordinated and managed formal face-to-face meeting with the FDA.
- Managed IND/NDA maintenance activities, including preparation of annual reports, protocol and information amendments, and FDA meeting packages.
Associate Director, Regulatory Affairs
Barrier Therapeutics
02.2004 - 06.2006
- Performed similar duties as below with greater independence on higher priority projects.
Manager, Regulatory Affairs
Barrier Therapeutics
02.2004 - 11.2005
- Served as regulatory lead on project teams and provided regulatory strategy.
- Provided global regulatory input and risk assessment for clinical development plans, clinical research strategies, and manufacturing issues.
- Coordinated and managed CRO activity with respect to NDA filing.
- Managed the review process of critical documents (i.e. Summary of Clinical Safety, Summary of Clinical Efficacy) essential to the CTD.
- Oversaw the regulatory submission of the company’s first New Drug Application (505(b)2) in CTD format to the Division of Dermatologic and Dental Drug Products (approved June 2006).
- Managed IND/NDA maintenance activities, including preparation of annual reports, protocol and information amendments, and FDA meeting packages.
- Held overall responsibilities for Canadian NDS submission to Health Canada.
Senior Regulatory Associate, Worldwide Regulatory Affairs
J&J Centocor, Inc.
03.2003 - 02.2004
- Performed similar duties as below with greater independence on higher priority projects.
- Developed strategy and coordinated compilation of Centocor’s first Common Technical Document (CTD) submission.
Regulatory Associate, Worldwide Regulatory Affairs
J&J Centocor, Inc.
06.2001 - 03.2003
- Prepared, submitted, and maintained clinical trial applications for countries in Europe, North America, and other regions (including Argentina and Australia/New Zealand).
- Managed IND/NDA maintenance activities, including preparation of annual reports, protocol and information amendments, and clinical investigator meeting packages.
- Participated in project teams and provided regulatory guidance.
- Directly contacted worldwide health authorities concerning clinical trial applications.
- Coordinated and managed activities with CRO’s.
- Assisted in the preparation of Orphan Drug Applications and responses to Health Authority questions.
Project Coordinator
Quintiles
06.1999 - 06.2001
- Coordinated activities between on-site Program Manager and program management teams.
- Implemented policies and procedures for effective and efficient management of projects.
- Worked with program management team to implement, monitor, and track project resources, budgets and timelines.
- Integrated and trained new program team members in program infrastructure.
- Conducted Medical Review audits of raw assessment data.
- Performed literature research and analysis on Single Use Devices (SUDs) in support of “White Paper” report for the Association of Disposable Device Manufacturers (ADDM).
Regulatory Associate I
Quintiles
02.1999 - 06.2000
- Participated in the preparation of IND, NDA, and BLA submissions.
- Managed IND/NDA maintenance activities, including preparation of annual reports to FDA, protocol and information amendments, and clinical investigator meeting packages.
- Performed Quality Control and Quality Assurance checks of materials prepared by clinical team, regulatory staff, and clients.
- Prepared project specific Standard Operating Procedures (SOPs) and work instructions for sponsors and internal team members.
Education
Bachelor of Science - Chemistry
Temple University
Philadelphia, Pennsylvania01.1998
Master of Business Administration - undefined
University of North Carolina
Chapel Hill, North Carolina01.2026
Skills
- Collaborative leadership
- Culture transformation
- Team management
- Policy development
Certification
NFPA 1001 Firefighter 1 certification (2020)
Timeline
Senior Director, Global Regulatory Affairs
Rocket Pharmaceuticals, Inc
06.2024 - Current
Senior Director, Global Regulatory Affairs, Oncology
Erasca Inc
06.2021 - 05.2024
Executive Director, Regulatory Affairs, Oncology
Hookipa Pharma
12.2020 - 06.2021
Deputy Director Regulatory Affairs, Oncology
Bayer Pharmaceuticals
02.2017 - 12.2020
Associate Director DRA Global Project Leader, Regulatory Affairs
Actelion Clinical Research
02.2013 - 02.2017
Senior Manager, Regulatory Affairs
Celgene Corporation
01.2009 - 02.2013
Senior Program Manager, Regulatory Affairs
Hoffman-La Roche
03.2007 - 11.2008
Senior Manager, Regulatory Affairs
OSI (Eyetech) Pharmaceuticals
07.2006 - 03.2007
Associate Director, Regulatory Affairs
Barrier Therapeutics
02.2004 - 06.2006
Manager, Regulatory Affairs
Barrier Therapeutics
02.2004 - 11.2005
Senior Regulatory Associate, Worldwide Regulatory Affairs
J&J Centocor, Inc.
03.2003 - 02.2004
Regulatory Associate, Worldwide Regulatory Affairs
J&J Centocor, Inc.
06.2001 - 03.2003
Project Coordinator
Quintiles
06.1999 - 06.2001
Regulatory Associate I
Quintiles
02.1999 - 06.2000
Master of Business Administration - undefined
University of North Carolina
Bachelor of Science - Chemistry
Temple University
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