Project Manager – Regulatory Affairs

Stark Pharma Solutions Inc; Kirkland (WA); On-site; USD 140,000 - 170,000; Full time

Job summary

Stark Pharma Solutions Inc. seeks a Project Manager Regulatory Affairs with 8+ years of global regulatory experience to lead registrations, submissions, and lifecycle activities.

You will coordinate regulatory dossiers, track timelines, and work with R&D, Quality, Supply Chain, Manufacturing, Marketing, Legal, and global affiliates to ensure submission readiness and regulatory compliance. The role requires strong project management and stakeholder communication skills, based in Washington with

Qualifications

• Bachelor's degree in Pharmacy, Life Sciences, Chemistry, Biotechnology or Regulatory Affairs.
• 8+ years of Regulatory Affairs experience.
• Experience with global product registrations and submission management.
• LATAM regulatory experience preferred; 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.

Skills

Regulatory project management

Regulatory submissions

Dossier management

Cross-functional coordination

Regulatory databases

Education

Bachelor's degree in Pharmacy/Life Sciences/Regulatory Affairs

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.