Regulatory Affairs Specialist
vor 1 Woche
About Teoxane SA
Teoxane SA is a leading manufacturer of hyaluronic acid-based dermal fillers and dermocosmetics. Our company is committed to providing high-quality products and exceptional customer service.
Job Summary
We are seeking a highly skilled Regulatory Affairs Officer to join our team in Asia. The successful candidate will be responsible for preparing and submitting registration dossiers for Asian countries, managing the follow-up of registration procedures, and validating promotional materials.
Main Responsibilities
- Registration and Compliance
- Prepare and submit registration dossiers for Asian countries in accordance with local regulations.
- Manage the follow-up of registration procedures and respond to requests from local competent authorities.
- Ensure maintenance of licenses in concerned countries.
- Inspections and Audits
- Prepare and support inspections conducted by competent authorities.
- Regulatory Partnerships
- Act as key contact and support for distributors and local regulatory partners in concerned countries.
- Regulatory Watch
- Monitor, interpret, and implement new regulatory requirements for concerned countries in collaboration with distributors and local regulatory partners.
Requirements
- Minimum 5 years of experience in a regulatory affairs position for medical devices.
- Team player with excellent communication and interpersonal skills.
- Ability to work in a fast-paced environment and adapt to changing priorities.
- Familiarity with Asian culture and language.
- Fluent in English with a good command of French.
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