Global Regulatory Affairs Project Manager - LATAM Focus

Stark Pharma Solutions Inc; Redmond (WA); On-site; USD 120,000 - 180,000; Full time

Job summary

Stark Pharma Solutions Inc. is seeking a seasoned Project Manager Regulatory Affairs in Washington to lead global product registrations and lifecycle activities.

You will manage regulatory submissions across international markets, coordinate variations, renewals, and respond to agency queries. The ideal candidate has 8+ years in Regulatory Affairs, strong project management, and LATAM regulatory experience (INVIMA preferred).

Qualifications

• Bachelor's degree in Pharmacy, Life Sciences, Chemistry, Biotechnology, Regulatory Affairs, or a related field.
• 8+ years of Regulatory Affairs experience.
• Strong experience with global product registrations, re-registrations, and renewals.
• Experience with regulatory dossier compilation and submission management.
• Experience managing multiple regulatory projects and timelines.
• LATAM regulatory experience; 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.
• Support regulatory remediation, gap closure, and registration recovery activities.
• Work with R&D, Quality, Supply Chain, Manufacturing, Marketing, Legal, and global affiliates.
• Track project timelines, milestones, risks, and launch readiness.
• Maintain regulatory databases, submission trackers, and document management systems.
• Provide regular project updates to stakeholders.
• Act as the regulatory project contact for global stakeholders, affiliates, and regulatory agencies.

Skills

Regulatory project management

Global regulatory submissions

Stakeholder management

LATAM regulatory experience

Education

Bachelor's degree in Pharmacy, Life Sciences, Chemistry, Biotechnology, Regulatory Affairs, or related field

Job description

Stark Pharma Solutions Inc. is seeking a seasoned Project Manager Regulatory Affairs in Washington to lead global product registrations and lifecycle activities.

You will manage regulatory submissions across international markets, coordinate variations, renewals, and respond to agency queries. The ideal candidate has 8+ years in Regulatory Affairs, strong project management, and LATAM regulatory experience (INVIMA preferred).