Regulatory Affairs Project Manager
Intellectt INC
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.
Vacancy posted 1 day ago
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