Regional Regulatory Affairs Manager

Teoxane Laboratories were established in Geneva, Switzerland, in 2003. They are specialized in the design and manufacturing of hyaluronic acid-based dermal fillers and dermocosmetics. Teoxane strength is to offer a global patient care. Using its products, practitioners are able to fill all kinds of wrinkles, from the finest to the deepest, to restore youthful volume to the face, and to treat the neck and décolleté, with natural results. The strength of Teoxane is also its human size and independence. Teoxane has a total freedom of thoughts, action and innovation which makes the company unique.

In the frame of the growth of our business, we are looking for a:

Regional Regulatory Affairs Manager
 

Role based in Bangkok with solid line reporting into Vice President, APAC and dotted line reporting into Geneva Regulatory Affairs.

Mission:

You will be responsible for ensuring the timely and compliant registration of Teoxane medical devices across Asia driving product launches, lifecycle management, and post-market surveillance in alignment with regional and global regulatory strategies. Close collaboration with the regulatory affairs team at our headquarters in Geneva will be essential.

This position requires close collaboration with the local team in Teoxane’s subsidiary, local distributors or regulatory third parties, and the Corporate Regulatory Affairs Team through dotted-line reporting to ensure alignment, compliance, and efficiency in all regulatory activities.

Main activities:

• Manage product lifecycle activities (registration, changes and renewal) across all countries in Asia:

• Assess regulatory impact of change controls proposed by Corporate.
• Prepare submission dossier based on documentation provided by RA Corporate according to local requirements.
• Ensure the follow-up of the registration procedure.
• Liaise with local distributors or local regulatory third parts for these activities.
• Ensure traceability by providing the RA Corporate with local submitted regulatory dossiers.

• Maintain up-to-date knowledge of country-specific regulatory requirements related the countries in Asia in collaboration with local distributors or local regulatory third parts and communicate regulatory changes to RA Corporate.
• Assist in audits and inspections by Competent Authorities.
• Validate promotional material related to Teoxane’s subsidiary and or distributors as required.
• Support post-market surveillance activities.

Your profile:

• Scientific or pharmaceutical background (master’s degree or equivalent).
• At least 7-10 years of experience in RA within MedTech sector, with experience in medical devices/ medical aesthetics preferred.
• Strong knowledge of local medical device regulations and competent authorities related to all Asian countries.
• Ability to solve complex issues with distributors or competent authorities.
• Proficiency in international standards (MDR, ISO13485, ISO 14971, GHTF, IMDRF).
• Experience in preparing and managing regulatory submissions.
• Ability to interpret and apply regulatory requirements to products.
• Intercultural communication: ability to collaborate with multicultural teams.
• Project management: tracking deadlines in dashboard, coordinating stakeholders, reporting to RA Corporate.
• Regulatory intelligence: proactive monitoring of regulatory changes in the assigned Region.
• Technical documentation: accuracy in file management, traceability and compliance.
• Proficient in English; Local language a plus.

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TEOXANE promotes equal opportunity and places at the heart of its human resources management policy the fight against all forms of discrimination based on age, gender, origin, disability, or any other personal characteristic.