This Senior Regulatory Affairs Program Lead position will work closely with in-country Regulatory Affairs representatives in the Asia Pacific to ensure efficient regulatory submission
Job Summary
This Senior Regulatory Affairs Program Lead position will work closely with in-country Regulatory Affairs representatives in the Asia Pacific to ensure efficient regulatory submission.
You will be responsible for creating, maintaining, and updating relevant regulatory dossier/STED/database for product registrations, change notifications or annual report for Asia Pacific Regions.
The anticipated base pay range for this position is $109,000.00 - $174,800.00.
Matching Summary
This Senior Regulatory Affairs Program Lead position will work closely with in-country Regulatory Affairs representatives in the Asia Pacific to ensure efficient regulatory submission.
Salary
Base: $109,000.00 - $174,800.00; Bonus/Equity: Not specified; Benefits: Vacation –120 hours per calendar year, Sick time - 40 hours per calendar year, Holiday pay –13 days per calendar year, Work, Personal and Family Time - up to 40 hours per calendar year, Parental Leave – 480 hours, Bereavement Leave – 240 hours for immediate family member, Caregiver Leave – 80 hours, Volunteer Leave – 32 hours, Military Spouse Time-Off – 80 hours
Skills & Requirements
Must-have
APAC regulatory submissions
product registration coordination
health authority inquiry response
regulatory strategy development
MDRiM project management
manufacturing process review
Nice-to-have
cross-functional collaboration
scientific/regulatory writing
understanding international RA requirements
adapting to regulatory landscape changes
Key Requirements
Bachelor's Degree required
6+ years Regulatory Affairs experience
Medical Device/Cardiovascular experience preferred
Class III Medical Device submission experience desired
Asia and Middle East submission experience desired