Senior Manager, Regulatory Affairs Cmc And Devices

Jobgether

United States
On-site
Regulatory strategy leadership
Cmc and device submissions
Global regulatory compliance
This role offers a pivotal opportunity to lead regulatory strategy and execution for clinical-stage biologics and drug-device combination products

Job Summary

  • This role offers a pivotal opportunity to lead regulatory strategy and execution for clinical-stage biologics and drug-device combination products.
  • You will be responsible for preparing, authoring, and coordinating high-quality CMC and device-related submissions that enable clinical trial initiation and progression.
  • The role requires meticulous attention to detail and direct influence on product development timelines.

Matching Summary

This role offers a pivotal opportunity to lead regulatory strategy and execution for clinical-stage biologics and drug-device combination products.

Skills & Requirements

Must-have

  • regulatory strategy leadership
  • CMC and device submissions
  • global regulatory compliance

Nice-to-have

  • collaborative environment
  • exceptional technical communication skills
  • ability to thrive in fast-paced settings

Key Requirements

  • hands-on experience in regulatory affairs
  • experience with clinical trial submissions
  • strong attention to detail

Work Rights

Not specified

Tailored Resume

Cover Letter