CMC Regulatory Affairs

---

Job description

Job Title: CMC Regulatory Affairs

Location: JFK Parkway, NJ

Duration: Long term

Required Qualifications:

• 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.

Thanks,

Kiran Veeraboina | Techno-Comp Inc.,

Phx 104

- provided by Dice