Do you have strong communication skills? Do you have exceptional judgement for communicating serious or potential issues upon review? If so, this Associate Director of Regulatory Affairs position is a great fit for you. Submit your resume to apply today!
- Create and implement regulatory CMC development and registration techniques
- Apply comprehensive knowledge of regulations for antibodies to projects to increase probability of regulatory success and compliance
- Organize and review modules of development apps, amendments, and additives for submission
- Make sure annual and periodic reports comply with reporting requirements
- Identify content requirements for submissions and oversee this content to ensure conformance with established regulations
- Examine change proposals for filing requirements and regulatory impact
- Experience with leading International regulatory filings, including electronic submissions, e.g., INDs, CTAs, NDAs, MAAs, annual reports, safety reporting, etc.
- BS/BA in a scientific discipline
- Advanced degree preferred
- 10 or more years of pharmaceutical regulatory CMC experience
- Leadership and liaison skills when interacting with Regulatory Agencies
- Ability to guide drug development and registration using scientific principles and regulatory CMC requirements