Job Summary
A staffing company is searching for a person to fill their position for a Telecommuting Regulatory Affairs Leader.
Core Responsibilities of this position include:
- Leading or supporting Agency meetings
- Leading and/or supporting global strategy and submissions
- Developing and implementing regulatory strategies
Must meet the following requirements for consideration:
- Travel to Waltham or CA with be approx 1 to 2 times a month
- Demonstrate effective cross-cultural awareness and capabilities
- A minimum of 10 years in the Pharmaceutical Industry, and a minimum 5 years regulatory management experience
- Strong interpersonal skills and the ability to deal effectively with a variety of personnel including medical, scientific, and manufacturing staff
- Excellent knowledge and understanding of applicable regulations
- Experience and knowledge in the preparation of major regulatory submissions and supportive amendments or supplements
