Project Manager – Regulatory Affairs

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

About The Company Stark Pharma Solutions Inc. is a global consulting and staffing partner established in 2014, serving the Pharmaceutical, Medical Device, Biotech, and IT industries across the USA, Canada, and India. We provide specialized consulting and staffing solutions across Quality & Validation, Regulatory Affairs, R&D, Manufacturing, Supply Chain, Project Management, and IT, with a focus on delivering tailored solutions that drive growth, operational excellence, and long-term client success.

About The Company Stark Pharma Solutions Inc. is a global consulting and staffing partner established in 2014, serving the Pharmaceutical, Medical Device, Biotech, and IT industries across the USA, Canada, and India. We provide specialized consulting and staffing solutions across Quality & Validation, Regulatory Affairs, R&D, Manufacturing, Supply Chain, Project Management, and IT, with a focus on delivering tailored solutions that drive growth, operational excellence, and long-term client success.

Position: Project Manager Regulatory Affairs

Location: Washington

Duration: Long Term

Job Overview We are seeking a Project Manager Regulatory Affairs with 8+ years of global regulatory experience. The ideal candidate will have strong experience in global product registrations, regulatory submissions, dossier management, and LATAM regulatory activities, preferably with INVIMA.

Key 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.

Required 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 Is Preferred. INVIMA experience is highly preferred. Experience with regulatory remediation, gap closure, registration recovery, or market continuity programs. Strong knowledge of regulatory documentation and quality compliance requirements. Experience with regulatory databases and document management systems. Strong project management, stakeholder management, communication, and problem-solving skills.

Stark Pharma is an Equal Opportunity Employer and welcomes qualified candidates from diverse backgrounds.