Job Title Small Molecule Consultant
Reporting to the Senior Director, Regulatory Affairs this position will provide support for Chemistry Manufacturing and Controls (CMC RA) for licensed and clinical products. The focus of this position will be small molecules though some biotechnology/protein products may be included in the portfolio. This position will provide product strategy and direction to commercial and clinical teams. Incumbent will be responsible for assuring the regulatory strategy is aligned with Health Authority requirements from a global perspective and assuring that regulatory submissions are on time and high quality. Experience preparing submissions is required along with working in a matrix environment and excellent people skills are also required.
Additional duties include coordination with our global manufacturing sites, integration of regulatory strategy with those sites and communication to senior management.
Provide support for other CMC projects as needed.
Proficient in MS Word, Excel, PowerPoint, MS Project, and Trackwise.
Excellent organizational and communication (written and verbal) skills.
Demonstrated ability to work successfully on project teams.
RAC certification preferred.
Previous experience working in a fast paced environment on multiple product lines
Manufacturing, QA/QC experience
Skills See above
- M.S. degree in a scientific discipline with 6 years regulatory experience. PhD is considered a plus.
- Knowledge of FDA regulatory submission requirements is essential.
- 4-6 years Biologics experience required.