Project Manager - Regulatory Affairs
Contract W2
Contract Corp To Corp
8 Months
Remote
$55 - $60/hr
Techridge, Inc.
Fitment
Dice Job Match Score™
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Job Details
Skills
- Regulatory Affairs
- Medical Device
- LATAM
- INVIMA
Summary
Job Title: Project Manager - Regulatory Affairs
Location: Bothell, WA (Onsite)
Position Type: Contract Role
Job Description:
- Lead global registration, re-registration, renewal, and lifecycle management activities across international markets.
- Establish and maintain a complete, well-organized, and submission-ready regulatory documentation repository to support global market registrations.
- Coordinate and execute pre-launch variations, renewals, amendments, and regulatory compliance activities.
- Review, compile, and dispatch high-quality regulatory dossiers to ensure successful first-cycle reviews by health authorities.
- Manage regulatory deficiencies, agency queries, and affiliate requests, ensuring timely and accurate responses.
- Collaborate with cross-functional teams (R&D, Quality, Supply Chain, Manufacturing, Marketing, Legal, and Affiliates) to support product registrations and launches.
- Monitor project plans, timelines, regulatory milestones, risks, and launch readiness; provide regular status updates to stakeholders.
- Maintain accuracy of regulatory databases, document management systems, and submission trackers.
- Act as the primary regulatory project contact for global stakeholders, affiliates, and regulatory agencies.
Education & Experience:
- Bachelor s degree in pharmacy, Life Sciences, Chemistry, Biotechnology, Regulatory Affairs, or a related scientific discipline.
- 8+ years of Regulatory Affairs experience in healthcare, consumer healthcare, oral care, cosmetics, medical devices, or related industries.
- Proven experience managing global product registrations, renewals, and re-registration projects.
- Experience leading regulatory remediation, gap closure, registration recovery, or compliance-driven market continuity programs.
- Experience managing registrations, renewals, or re-registrations with INVIMA and other LATAM regulatory authorities preferred.
Skills:
- Experience in global regulatory requirements, dossier compilation, and new product registration processes.
- Excellent project management skills with the ability to manage multiple regulatory projects and timelines simultaneously.
- In-depth knowledge of technical documentation, quality compliance requirements, and current health authority guidance.
- Strong leadership, stakeholder management, negotiation, and cross-functional collaboration skills.
- Excellent problem-solving, risk management, and conflict resolution capabilities.
- Experience with document management systems to maintain submission-ready regulatory dossiers, track registrations and manage document lifecycles.
Employers have access to artificial intelligence language tools (“AI”) that help generate and enhance job descriptions and AI may have been used to create this description. The position description has been reviewed for accuracy and Dice believes it to correctly reflect the job opportunity.
- Dice Id: 10125172
- Position Id: 9091325
- Posted 7 hours ago
Company Info
About Techridge, Inc.
We believe we have the know-how to do it right the first time and we also understand that our client focus will always be on
-High Quality
-Cost Effectiveness
-Total Convenience
-Continuous Training
-Emphasis on Security
-Industry recognized SDLC
-Intelligent Communication
Technology and business knowledge go hand in hand in today s digital age, it very important to remember that technology will always remains a support mechanism for business. The greatest resource that makes any business successful is people, people who understand your business needs and technology. Techridge s hiring processes allows us to hire the right people based technical expertise on Attitude, Communication, Technical and Industry knowledge. Most of our employees have post graduate degrees.
At Techridge, we satisfy your need to keep up with lightning fast technology, manage constant system updates and control ongoing work by providing qualified IT professionals. People with the expertise to help you charge ahead of industry trends and the competition.
Careers
-High Quality
-Cost Effectiveness
-Total Convenience
-Continuous Training
-Emphasis on Security
-Industry recognized SDLC
-Intelligent Communication
Technology and business knowledge go hand in hand in today s digital age, it very important to remember that technology will always remains a support mechanism for business. The greatest resource that makes any business successful is people, people who understand your business needs and technology. Techridge s hiring processes allows us to hire the right people based technical expertise on Attitude, Communication, Technical and Industry knowledge. Most of our employees have post graduate degrees.
At Techridge, we satisfy your need to keep up with lightning fast technology, manage constant system updates and control ongoing work by providing qualified IT professionals. People with the expertise to help you charge ahead of industry trends and the competition.
Careers
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