Job Summary
A pharmaceutical company is in need of a Remote Regulatory Affairs Manager.
Individual must be able to fulfill the following responsibilities:
- Develop and implement regulatory strategies
- Act as liaison with regulatory authorities to facilitate the prompt review and approval of applications
- Understand regulatory environment and communicates priorities to global stakeholders
Applicants must meet the following qualifications:
- Ability to communicate complex information and analyses
- B.S. Scientific Degree plus 7 years experience
- Proven ability in developing and implementing regulatory strategy
- Experience preparing and submitting INDs and/or CTAs, NDAs/ MAAs
- Demonstrated strategic thinking and ability to integrate strategies into actionable plans
- Proven ability to consistently deliver to time, cost, and quality standards
