Job Summary
A staffing agency is searching for a person to fill their position for a Virtual Regulatory Affairs Head.
Core Responsibilities of this position include:
- Providing counsel, training, and interpretation of FDA’s and other regulatory authorities’ feedback, policies and guidelines
- Assisting as a liaison between the company and regulatory authorities
- Interpreting, planning, and communicating requirements to ensure FDA approvals are obtained
Applicants must meet the following qualifications:
- Represent the company before regulatory authorities
- BS, MS, or Ph.D. in a Life Sciences discipline or equivalent
- 15 years of experience in regulatory and at least 10 years of progressive leadership experience in the Pharmaceutical or Biotechnology industry
- Strong understanding of the drug development process
- Familiarity with cardiovascular and/or lipid regulating drug development and regulatory requirements in major markets
- Extensive experience in cGMP and other Regulatory (CMC, preclinical) compliance requirements
