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International Regulatory Affairs Specialist
BDInternational Regulatory Affairs Specialist collaborating with global teams to develop regulatory submission strategies. Ensuring compliance with international regulations for product registrations.
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
ATS Keywords
✓ Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
Regulatory AffairsLife SciencesBiomedical EngineeringPharmacyTechnical DocumentationRegulatory ProceduresQuality SystemsISO 13485Project ManagementSubmission Management
Soft Skills
Strong Written CommunicationStrong Verbal CommunicationOrganizational Skills