Regulatory Affairs Project Manager

Job Title: Regulatory Affairs Project Manager

Location: Bothell, WA

Duration: 06+ Months Contract

Must-Have Skills:

• 8+ years of Global Regulatory Affairs experience
• Global product registrations, renewals, and re-registrations
• Regulatory dossier compilation and submission management
• LATAM Regulatory experience, preferably INVIMA

Responsibilities:

• Lead global product registration, renewal, and lifecycle activities.
• Compile and manage regulatory dossiers and submissions.
• Handle regulatory deficiencies, agency queries, and compliance activities.
• Coordinate with R&D, Quality, Manufacturing, Supply Chain, Marketing, and global affiliates.
• Track regulatory timelines, milestones, risks, and launch readiness.
• Maintain regulatory databases, submission trackers, and documentation.
• Support regulatory remediation, gap closure, and registration recovery activities.

Qualifications:

• Bachelor's degree in Pharmacy, Life Sciences, Biotechnology, Regulatory Affairs, or related field.
• 8+ years of Regulatory Affairs experience, preferably in Medical Devices.
• Experience with global registrations and LATAM regulatory authorities.
• Strong project management, stakeholder management, and communication skills.
• Experience with regulatory document management systems.