Own regulatory strategy and submissions that bring Mynarix products to market and keep them compliant. You will be the bridge between our science and global health authorities.
What you'll do
- Prepare and manage ANDA/NDA, variation, and renewal submissions.
- Define regulatory strategy for new and existing products.
- Serve as primary liaison with FDA and international agencies.
- Review labeling, promotional, and change-control documentation for compliance.
What you'll bring
- ✓Bachelor's in life sciences; advanced degree or RAC a plus.
- ✓5+ years in regulatory affairs for pharmaceuticals.
- ✓Direct experience with FDA submissions and agency correspondence.
- ✓Excellent scientific writing and project-management skills.
1 About you
2 Experience
3 Questions