Offer summary
Qualifications:
Bachelor's or Master's degree in science, engineering, or related field, Proven regulatory affairs experience, Experience with marketing authorization, Proven project management experience.
Key responsabilities:
- Perform CMC compliance activities and gap analysis
- Lead product lifecycle strategy and regulatory milestones
- Collaborate with clients for change management compliance
- Manage execution of CMC documentation for approvals
- Identify and escalate potential regulatory issues