Responsible for overseeing global regulatory strategies and ensuring that products comply with regulations throughout their entire lifecycle, from development through post-approval.

Requirements

• Bachelor's and/or Master's degree
• Minimum of 10 years of experience in the pharmaceutical industry, with at least 5+ years specifically in regulatory affairs.
• Experience in preparation of IND/CTA and NDA/MAA submissions and electronic Common Technical Document eCTD preparation.
• Experience with injectable drug products, aseptic manufacturing processes and medical devices is preferred.
• Direct experience with OPDP and marketed products preferred.
• Direct experience with FDA required and international experience preferred.
• Moderate travel (up to 10-20%).