Localization Specialist / Regulatory Affairs Specialist

Role Description
The Localization Specialist / Regulatory Affairs Specialist is responsible for adapting business content for different languages and markets while ensuring that documentation, product information, and operational materials comply with applicable regulatory requirements. This role combines language localization, cross-cultural communication, regulatory documentation, and compliance coordination to support accurate, consistent, and market-appropriate business operations.
Key responsibilities include translating, reviewing, and localizing documents, digital content, product descriptions, user materials, internal communications, and other business-related information. The specialist ensures that localized content maintains the original meaning, follows appropriate terminology, and reflects the linguistic, cultural, and formatting requirements of the intended audience.
The role also involves researching applicable laws, regulations, industry guidelines, and market-specific requirements relevant to products, services, and business activities. Responsibilities include preparing and reviewing regulatory submissions, maintaining compliance records, organizing supporting documentation, and monitoring regulatory updates that may affect business operations or market access.
The specialist coordinates with internal departments, external language service providers, regulatory authorities, and other relevant stakeholders to facilitate document reviews, resolve terminology discrepancies, and ensure that required information is accurate and submitted within established deadlines. The role also supports the review of labels, claims, technical documents, policies, and product-related materials to maintain consistency between localized content and regulatory expectations.
Additionally, the specialist maintains terminology databases, translation memories, regulatory tracking records, and document control systems. The position contributes to quality assurance processes, identifies potential documentation or compliance issues, supports corrective updates, and helps improve localization workflows and regulatory documentation practices. This role requires strong analytical skills, meticulous attention to detail, effective communication, and the ability to manage multiple projects while maintaining accuracy, consistency, and regulatory alignment.
Qualifications
Degree in Translation, Linguistics, Regulatory Affairs, Life Sciences, Business Administration, Law, or a related discipline.
Strong written and verbal communication skills, with excellent language accuracy and attention to detail.
Knowledge of localization processes, translation quality assurance, and cross-cultural communication principles.
Understanding of regulatory documentation, compliance procedures, and relevant industry guidelines.
Ability to research regulatory requirements and interpret technical or policy-related information.
Familiarity with translation management systems, terminology databases, document control platforms, and Microsoft Office applications.
Ability to review, organize, and maintain accurate technical, regulatory, and localized documentation.
Strong analytical, organizational, and problem-solving skills.
Ability to coordinate with multidisciplinary teams and external stakeholders.
Commitment to confidentiality, document accuracy, quality standards, and continuous process improvement.

Work arrangement
Yes