Provide regulatory guidance and strategy to Integrated Project Teams (IPT's) and other functional teams leading to sound scientific development programs and successful registration for new compounds and new indications. Represent Sankyo during FDA interactions; able to schedule and lead meetings with FDA and prepare company personnel for FDA interactions. Determine the content for regulatory submissions as well as evaluate submissions for accuracy. Prepare regulatory responses to requests from health authorities. Direct preparation of annual reports for both marketed and developmental products.
- Organize and manage the preparation (content and format) of all types of submissions to FDA. Coordinates activities required for timely and accurate reporting of information to existing submissions.
- Facilitate and support liaison activities with functional groups within Daiichi Sankyo Pharma Development and Corporate partners related to assigned products/project areas.
- Provide regulatory support and guidance and manage regulatory submissions
- Keep current with Regulatory guidelines and assists in educating the organization on evolving Regulatory Affairs CMC (RACMC) issues and regulations. Promotes global RACMC services to CMC Operations, Pharmaceutical Development, and Clinical Supplies’ Operations within the organization.
- Supervise the identification and compilation of required documentation for submission. Prioritizes workload.
- Evaluate content and adequacy of submissions and identify deficiencies.
Qualifications: Successful candidates will be able to meet the qualifications below with or without a reasonable accommodation.
Education Qualifications (from an accredited college or university)
- Bachelor's Degree Life Science Degree required
- Master's Degree preferred
- PharmD preferred
- 10 or More Years in the pharmaceutical industry with significant experience in scientific/regulatory fields preferred
- Experience in international Regulatory Affairs– CMC preferred
- Clinical Works
- Pharmaceutical Development