- Opportunity to join a high growth, publicly traded biotech organization
- Represent Regulatory Affairs CMC for emerging portfolio of biologics products
About Our Client
Our client is a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of novel treatments for patients suffering from hematologic and musculoskeletal disorders.
- Ensures high-quality and on-time submissions that align with company strategies and Health Authority requirements.
- Provides regulatory and scientific expertise to develop regulatory CMC strategies for biologics product development and commercialization.
- Supports preparation for CMC meetings
- Represents Regulatory Affairs CMC
- Develops relationships with and proactively communicates issues with key internal colleagues.
- Develops and implements best practices based on current and emerging industry trends
MPI does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity or expression, national origin, age, disability, veteran status, marital status, or based on an individual's status in any group or class protected by applicable federal, state or local law. MPI encourages applications from minorities, women, the disabled, protected veterans and all other qualified applicants.
The Successful Applicant
- Bachelor of Science in a scientific discipline, advanced degree preferred
- 10+ years biopharmaceutical experience
- At least 7 years Regulatory CMC biopharmaceutical experience
- Extensive biologics experience
- Direct experience leading interactions with regulatory health authorities
- Extensive experience in developing documents for IND and BLA submissions in eCTD format
- High-level knowledge and understanding of regulations and guidance
What's on Offer
- Competitive base salary and benefit package
- Stock options
- Opportunity for career advancement and development
- Opportunity to help build out Regulatory CMC function
- Work on diverse product pipeline moving through to commercialization
- Remote flexibility