Job Summary
A pharmaceutical and biotechnology development company is seeking a Remote Regulatory Affairs Chemistry Manufacturing and Controls Manager.
Individual must be able to fulfill the following responsibilities:
- Prepare and submit complex regulatory documents
- Work cooperatively with regional regulatory sites to support the accurate and timely communication of critical information
- Provides input to senior Regulatory Affairs CMC professionals in the preparation of country specific labeling
Must meet the following requirements for consideration:
- A Bachelor's Degree and a minimum of seven (7) years of relevant industry experience in Regulatory Affairs CMC
- OR a Master's Degree and a minimum of five (5) years of experience in Regulatory Affairs CMC
- Excellent organizational skills and the ability to work on a number of projects with tight timelines
- Excellent verbal and written communication skills
- Knowledgeable of regulatory requirements