Job Summary
A cancer-focused biopharmaceutical company is seeking a Remote Oncology Global Regulatory Affairs Vice President.
Core Responsibilities Include:
- Developing and executing Regulatory strategies, policies, programs, and procedure
- Representing company interests with national government agencies, industry associations, etc
- Overseeing preparation of company regulatory submissions
Applicants must meet the following qualifications:
- Advanced degree in the life science
- OR the equivalent combination of education and experience
- 15 years’ experience in the pharmaceutical/biotechnology industry
- 10 years in the Regulatory Affairs or related function(s)
- Experience with regulatory submissions including IND’s/CTA’s, IMPD’s and NDAs/MAAs
- Record of successful interactions with FDA/EMA and other global regulatory authorities