Global Regulatory Affairs Project Manager

Stark Pharma Solutions Inc; Kirkland (WA); On-site; USD 140,000 - 170,000; Full time

Job summary

Stark Pharma Solutions Inc. seeks a Project Manager Regulatory Affairs with 8+ years of global regulatory experience to lead registrations, submissions, and lifecycle activities.

You will coordinate regulatory dossiers, track timelines, and work with R&D, Quality, Supply Chain, Manufacturing, Marketing, Legal, and global affiliates to ensure submission readiness and regulatory compliance. The role requires strong project management and stakeholder communication skills, based in Washington with

Qualifications

• Bachelor's degree in Pharmacy, Life Sciences, Chemistry, Biotechnology or Regulatory Affairs.
• 8+ years of Regulatory Affairs experience.
• Experience with global product registrations and submission management.
• LATAM regulatory experience preferred; INVIMA experience highly preferred.

Responsibilities

• Lead global product registrations, re-registrations, renewals, and lifecycle activities.
• Manage regulatory submissions across international markets.
• Compile, review, and maintain regulatory dossiers and submission documents.
• Coordinate variations, renewals, amendments, and regulatory compliance activities.
• Manage regulatory deficiencies, agency queries, and affiliate requests.
• Maintain accurate and submission-ready regulatory documentation.

Skills

Regulatory project management

Regulatory submissions

Dossier management

Cross-functional coordination

Regulatory databases

Education

Bachelor's degree in Pharmacy/Life Sciences/Regulatory Affairs

Job description

Stark Pharma Solutions Inc. seeks a Project Manager Regulatory Affairs with 8+ years of global regulatory experience to lead registrations, submissions, and lifecycle activities.

You will coordinate regulatory dossiers, track timelines, and work with R&D, Quality, Supply Chain, Manufacturing, Marketing, Legal, and global affiliates to ensure submission readiness and regulatory compliance. The role requires strong project management and stakeholder communication skills, based in Washington with