- Remote
- Remote
- Full-time · Manager
- $130K–$250K per year
- 10+ years
Lead regulatory strategy and execution for Mapp Biopharmaceutical’s product development programs, managing FDA interactions, submissions, and compliance across all disciplines.
Compensation
Mapp's anticipated pay scale for this position is $130,000 to $250,000, plus any applicable bonuses.
Responsibilities
- Ensures that all regulatory goals are met and are in compliance with current industry standards and global regulations
- Serves as a steward of Regulatory Affairs processes, procedures, and tools
- Contributes to coordination, preparation, and timely submission of all regulatory documents
- Develops regulatory strategies for the company and product development teams
- Facilitates FDA interactions, presentations and negotiations
Requirements
- Bachelor's degree in a related field
- Advanced degree or equivalent preferred
- Nice to have: Monoclonal antibody development
- Nice to have: BLA submission
- Nice to have: Commercialization of monoclonal antibody therapies