Global Coordinator

Global Coordinator

Location: San Diego, California

Category: Regulatory Affairs

Salary: Apply for details

Country: United States

Employment: Contract

Worksite: On-Site

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Job Description

Target PR Range:31-41/hr DOE

Duties

• Position Summary

• The Global Coordinator will support growing international footprint by coordinating operational activities required to register, launch, and sustain products in global markets outside the United States. This role will work closely with Manufacturing, Supply Chain, Quality, Regulatory, and other internal stakeholders to support ROW submissions, partner requests, compliance activities, and ongoing market maintenance.

• The successful candidate will be highly organized, process-oriented, and capable of managing multiple concurrent activities across markets, partners, and regulatory frameworks. This position focuses on coordination, documentation management, process execution, issue resolution, and ensuring operational requests are efficiently coordinated through completion, while supporting activities within a regulated environment requiring familiarity with GMP, GxP, and quality system requirements.

Key Responsibilities

• Global Expansion Coordination

• Coordinate cross-functional activities supporting global submissions, launches, and post-launch market maintenance

• Collaborate for operational activities across Manufacturing, Supply Chain, Quality, Regulatory, and other internal partners as needed

• Track critical milestones, deliverables, risks, decisions, and dependencies across multiple markets

• Facilitate communication and alignment between internal stakeholders and external commercial partners

• Documentation & Compliance Support

• Coordinate collection, maintenance, and distribution of operational and compliance documentation

• Manage recurring requests for market-specific documentation including CPPs, Certificates of Origin, GMP certificates, manufacturing declarations, quality documentation, and other submission support materials

• Identify document owners, approvers, and signature requirements

• Maintain organized repositories and standardized documentation packages to support reuse across markets

• Support development and continuous improvement of submission support tools, templates, and document libraries

• Apply working knowledge of GMP, GxP, and quality system requirements when coordinating documentation, compliance activities, and market-specific operational requests

• Operational Readiness & Market Maintenance

• Coordinate annual compliance activities and recurring market requirements

• Monitor, track and coordinate implementation of post-approval changes via quality management system (QMS) and assess impacts across multiple markets and partners

• Support artwork, packaging, labeling, and product configuration coordination

• Assist with knowledge transfer activities and readiness planning associated with new market entries

• Ensure ongoing visibility of operational requirements as products progress from submission through commercial supply

• Process Management & Continuous Improvement

• Develop and maintain scalable processes that support increasing numbers of international markets

• Manage trackers, dashboards, and reporting tools for ROW activities

• Support development of future global operating model and ROW support framework

• Maintain global market requirement databases and trackers

• Identify opportunities to automate, simplify, and standardize ROW processes

• Develop and implement systems and tools that improve coordination and visibility

• Develop reporting and metrics to support leadership decision-making

Skills

• Skills & Competencies

• Exceptional organization and project coordination skills.

• Strong attention to detail and follow-through.

• Ability to manage multiple priorities simultaneously.

• Excellent communication and stakeholder management skills.

• Comfortable working across time zones, cultures, and external partner organizations.

• Strong Microsoft Office, SharePoint, Smartsheet, and reporting tool proficiency.

• Experience using an e-QMS if preferred.

• Demonstrated ability to develop and improve operational processes.

Education

Qualifications

Education

• Bachelor’s degree in Manufacturing, Supply Chain, Life Sciences, Business, Operations, Engineering, or related discipline.

Experience

• 2-4 years of experience in pharmaceutical, biotechnology, medical device, or regulated industries.

• Experience coordinating cross-functional projects and stakeholders.

• Experience working with GxP documentation, electronic quality system (QMS), compliance, regulatory submissions, or operational processes.

• Global or international business experience preferred.

• Equal Opportunity Employer

• We are proud to be an equal opportunity employer. We welcome and encourage applications from all qualified candidates regardless of race, sex, gender identity or expression, disability, age, religion or belief, sexual orientation, or any other characteristic protected by applicable laws and regulations. It is our policy not to discriminate against any applicant or employee, and we are committed to fostering a diverse, inclusive, and respectful work environment across all locations in which we operate. We believe that diversity, equity, and inclusion are fundamental to our mission and enhance our ability to serve clients globally. If you have a disability or require any reasonable accommodations during the application or interview process, please inform your recruiter or contact us(opens in new tab) directly so that we can explore the appropriate arrangements.

• Fraud Alert

• Candidate safety is a top priority at Planet Pharma. The industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly, never provide banking information during the application process and always double check the email address of the Recruiter to ensure it’s from an official Planet Pharma domain (@planet-pharma.com, @planet-pharma.co.uk, and @ppgadvisorypartners.com) and not a domain with an alternative extension like .net, .org or .jobs.

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