International Regulatory Affairs Specialist

International Regulatory Affairs Specialist collaborating with global teams to develop regulatory submission strategies. Ensuring compliance with international regulations for product registrations.

Posted 7/7/2026full-timeSparks • Maryland • 🇺🇸 United StatesJuniorMid-LevelWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in regulatory submission processes and lifecycle management, with a strong ability to compile and review technical documentation according to country-specific requirements. Proficient in collaborating with cross-functional teams and managing multiple international product registration projects simultaneously.

Highest-signal resume keywords

Regulatory Submission ProcessesTechnical Documentation CompilationCross-Functional CoordinationSOPs and Regulatory ProceduresMicrosoft Office Proficiency

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Regulatory AffairsLife SciencesBiomedical EngineeringPharmacyTechnical DocumentationRegulatory ProceduresQuality SystemsISO 13485Project ManagementSubmission Management

Soft Skills

Strong Written CommunicationStrong Verbal CommunicationOrganizational Skills

Tools & Technologies

Microsoft ExcelMicrosoft WordMicrosoft PowerPoint

Industry Keywords

Product RegistrationGlobal Regulatory AffairsInternational RegulatoryCross-Functional TeamsRegional Affiliates

About the role

Key responsibilities & impact

Collaborating with regional colleagues to develop strategies for moderately complex submissions to regulatory agencies worldwide
Interpreting regulations and guidance’s ex-U.S. and communicating to the country how these impact the ability to register
Coordinating and supporting worldwide product registration requests
Interface with global international regulatory and marketing contacts to support regional registration requirements
Developing and maintaining department procedures for international product registrations
Assembling technical information according to registration requirements

Requirements

What you’ll need

Bachelor’s degree in Regulatory Affairs, Life Sciences, Biomedical Engineering, Pharmacy, or related scientific/technical discipline
Experience coordinating cross-functional inputs (R&D, QA, Manufacturing, Marketing)
Ability to compile and review technical documentation in accordance with country-specific requirements
Understanding of regulatory submission processes and lifecycle management
Strong written and verbal communication skills
Experience working with global teams, regional affiliates, or distributors
Familiarity with SOPs, regulatory procedures, and quality systems (e.g., ISO 13485)
Strong organizational skills and ability to manage multiple submissions/projects simultaneously
Proficiency in Microsoft Office tools (Excel, Word, PowerPoint)

Benefits

Comp & perks

Health insurance
Retirement plans
Paid time off
Flexible work arrangements
Professional development opportunities