Job Title: CMC Regulatory Affairs
Location: JFK Parkway, NJ
Duration: Long term
- Strong experience in CMC requirements for small molecule/biologic products.
- Post approval regulatory CMC experience, at least 5 years
- Device/Instrument experience
- Proven experience in critically reviewing detailed scientific information to assess technical merits and suitability of scientific rationale to ensure information is presented clearly and conclusions are adequately supported by data.
- Demonstrated superior oral and written communication skills in multicultural settings and ability to communicate complex issues in a succinct and logical manner. Strong listening skills.
- Demonstrated sound understanding of related fields (e.g., manufacturing, analytical, quality assurance) and the ability to be creative and imaginative in the approach to new and diverse problem solving.
- Demonstrated ability to generate innovative solutions to complex regulatory problems and effectively work with and communicate to key stakeholders.
- Demonstrated flexibility in responding to changing priorities or dealing with unexpected events
- Demonstrated effective leadership, communication, interpersonal and negotiating skills.
- Ability to lead a team of direct or matrixed colleagues to deliver on business commitments and project timelines.
Kiran Veeraboina | Techno-Comp Inc.,