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.
