Localization Specialist / Regulatory Affairs Specialist

Role Description
The Localization Specialist / Regulatory Affairs Specialist is responsible for adapting content for different languages and markets while supporting regulatory documentation, compliance monitoring, and the implementation of applicable industry requirements. This role combines localization coordination, language quality assurance, regulatory research, documentation management, and compliance support to ensure that organizational content is culturally appropriate, accurate, and aligned with relevant standards and regulations.
Localization responsibilities include reviewing, translating, adapting, and coordinating content for different linguistic and cultural audiences. The specialist works with translators, editors, designers, marketing teams, and other stakeholders to ensure that documents, websites, product information, digital interfaces, and communication materials maintain consistent terminology and messaging. Duties also include managing localization schedules, maintaining translation glossaries, reviewing linguistic quality, coordinating proofreading, and verifying that localized materials meet established brand and formatting guidelines. The role involves identifying cultural differences, resolving language inconsistencies, and improving localization workflows to support clear communication across international markets.
Regulatory affairs responsibilities include researching applicable regulations, monitoring regulatory updates, and supporting the preparation and maintenance of compliance documentation. The specialist assists with organizing regulatory submissions, reviewing technical documents, maintaining regulatory records, and coordinating information required for internal reviews or external assessments. Additional duties include tracking submission deadlines, updating regulatory databases, preparing compliance summaries, and communicating relevant requirements to appropriate departments. The role helps ensure that documentation is complete, accurate, properly controlled, and consistent with applicable regulatory standards.
The position also supports cross-functional coordination between localization teams, regulatory personnel, product departments, quality assurance teams, and external service providers. Responsibilities include maintaining project schedules, tracking documentation status, reviewing deliverables, and identifying issues that may affect content quality or regulatory compliance. The specialist assists with developing standardized procedures, improving document management practices, and ensuring that confidential or sensitive information is handled appropriately. Through structured localization management and systematic regulatory support, the role contributes to consistent international communication, reliable documentation, and effective compliance processes.
Qualifications
Diploma or degree in Translation, Linguistics, International Business, Regulatory Affairs, Communications, Life Sciences, Law, or a related field.
Understanding of localization workflows, linguistic quality assurance, regulatory documentation, and compliance procedures.
Ability to review, edit, organize, and maintain multilingual content and regulatory records.
Knowledge of terminology management, translation review, cultural adaptation, and document quality standards.
Understanding of regulatory research, submission tracking, compliance monitoring, and document control principles.
Familiarity with translation management systems, computer-assisted translation tools, spreadsheets, and document management platforms.
Ability to research regulatory requirements and summarize relevant information accurately.
Strong written communication, proofreading, and analytical skills.
Excellent organizational and time-management abilities, including the coordination of multiple projects and deadlines.
High attention to detail when reviewing translations, technical content, regulatory records, and compliance documentation.
Ability to communicate effectively with internal departments, translators, external consultants, and other stakeholders.
Strong problem-solving skills and the ability to identify inconsistencies, documentation gaps, and workflow improvements.
Commitment to confidentiality, information accuracy, quality standards, and compliance with applicable policies.
Ability to adapt to changing market requirements, language needs, and regulatory updates.
A collaborative and systematic approach to maintaining localization quality and supporting regulatory compliance.

Work arrangement
Yes