Replies to post #391503 on Anavex Life Sciences Corp (AVXL)

[XenaLives]

Experience
Anavex Life Sciences logo
Senior Vice President Regulatory Affairs
Anavex Life Sciences · Full-timeAnavex Life Sciences · Full-time
Oct 2022 - Present · 3 mosOct 2022 - Present · 3 mos
New York City Metropolitan AreaNew York City Metropolitan Area
Lead and oversee all regulatory affairs activity and member of senior management


Vice President Regulatory Affairs
Otsuka Pharmaceutical Dev and Comm | Otsuka European Dev and Comm
Oct 2016 - Dec 2020 · 4 yrs 3 mos
Princeton NJ, Frankfurt Germany, Wexham UK
Vice President US/Global Regulatory Affairs and Advisor European Regulatory Affairs. Responsible for CNS, Cardio Renal, Oncology and Digital Therapeutic Areas, Labeling, CMC Reg. Aff.and Medical Writing.Vice President US/Global Regulatory Affairs and Advisor European Regulatory Affairs. Responsible for CNS, Cardio Renal, Oncology and Digital Therapeutic Areas, Labeling, CMC Reg. Aff.and Medical Writing.

Otsuka Pharmaceutical Companies (U.S.)
11 yrs 9 mos11 yrs 9 mos
Vice President Global Regulatory Affairs and Head US and European Regulatory Affairs Depts.Vice President Global Regulatory Affairs and Head US and European Regulatory Affairs Depts.
Full-time
Apr 2009 - Dec 2020 · 11 yrs 9 mos
Princeton, New Jersey, United StatesPrinceton, New Jersey, United States
Senior Director Regulatory AffairsSenior Director Regulatory Affairs
Oct 2009 - Jun 2013 · 3 yrs 9 mos
Senior Director of Regulatory Affairs - therapeutic area head for CNS.Senior Director of Regulatory Affairs - therapeutic area head for CNS.

Vice President Regulatory Affairs
Otsuka Pharmaceutical Development and Commercialization
Jun 2013 - Oct 2016 · 3 yrs 5 mos
Princeton NJ

Senior Director Head Labeling Operations
Johnson & Johnson
Apr 2006 - Mar 2009 · 3 yrs
-Cross company worldwide head of Labeling Ops and Medicinal Product Dictionary
-Lead all logistical and technology functions for strategic labeling
-Implement eLabeling, and tracking functions (SPL/PLR)
-Implement and evolve MPD to satisfy regulations providing global J&J pharmacy product information
-Manage global team of 13-

Johnson & Johnson
8 yrs 1 mo8 yrs 1 mo
Senior Director Head Business Support Management - Regulatory Affairs and QASenior Director Head Business Support Management - Regulatory Affairs and QA
2005 - 2006 · 1 yr
-Worldwide Head of Regulatory Affairs business support including Communications, Training, Knowledge, Finance and Resource Mgmt.
-As member of Sr. Leadership team provided guidance and insight on regulatory and business support
-Member Process Excellence Leadership team
-Chairperson Cross Pharma Reg. Aff. Info. Sharing Committee
-Managed team of 8


Senior Director Head Drug Evaluation - Regulatory Affairs and Quality Assurance
2001 - 2005 · 4 yrs
-Worldwide Head of early phase strategic reg. aff. and QA group
-Responsible for global health authority interactions and all therapeutic areas including CNS, GI, Oncology, Endocrinology, Anti-infectives, Respiratory, Immunology, Men’s/Women’s Health
-Primary contact to Business Development and Licensing partners
-As member of Sr. Mgmt team for J&J early drug development provided regulatory and QA guidance
-Managed global team of 16

Associate Director Regulatory Aff. and Project Management
1999 - 2001 · 2 yrs
-Designed and implemented concept for and led cross-functional teams on due
diligence licensing opportunities for Project Management group.
-Worldwide Reg. Aff. Project Leader for Proof of Principle (Entry
into Humans) program for all therapeutic areas
-Managed team of 5-Designed and implemented concept for and led cross-functional teams on due diligence licensing opportunities for Project Management group.
-Worldwide Reg. Aff. Project Leader for Proof of Principle (Entry into Humans) program for all therapeutic areas
-Managed team of 5

Assistant Director Regulatory Affairs
1998 - 1999 · 1 yr
-Worldwide Regulatory Project Leader for Proof of Principle
-Guided project teams on FDA and international regulations
-Managed team of 4-Worldwide Regulatory Project Leader for Proof of Principle -Guided project teams on FDA and international regulations
-Managed team of 4