Overseas Pharmaceutical Operations Manager
Job Summary
You will lead the overseas expansion of pharmaceutical and cosmetic products into South Korea, Taiwan, and ASEAN markets by managing regulatory affairs. This role involves coordinating with cross-functional teams to ensure product compliance, safety, and successful market entry. You will oversee documentation, labeling, and regulatory strategy throughout the product lifecycle.
Responsibilities
- Manage regulatory affairs for overseas expansion.
- Ensure compliance with regional laws in Korea, Taiwan, and ASEAN.
- Prepare regulatory documents and product dossiers.
- Oversee labeling and promotional material reviews.
Required Skills
- 2+ years experience in cosmetics/pharma regulations.
- Fluent Japanese (N1).
- Knowledge of international cosmetic laws.
- Proactive project management skills.
Job Details
### Job Description
You will be responsible for handling regulatory affairs necessary for overseas expansion, in collaboration with the product planning, development, production, and online departments.
* Gathering and sharing information on the latest regulatory affairs in South Korea, Taiwan, and other ASEAN countries.
* Confirming the feasibility of raw material use, allergen regulations, and ingredient limits.
* Determining relevant laws and regulations such as VOC regulations, SDS, and hazardous materials.
* Creating and submitting regulatory application documents, PIFs, and dossiers for each country.
* Regulatory checks and management of formulations and ingredients.
* Creating and proofreading local language labels (Korean, Traditional Chinese, English, etc.).
* Reviewing product pages, training materials, and advertisements from a regulatory perspective.
* Managing the progress of overseas expansion projects and coordinating with related departments.
### Job Requirements
* Experience in pharmaceutical and customs clearance operations related to cosmetics or general merchandise products (2 years or more).
* Knowledge of relevant laws and regulations in Korea, Taiwan, and ASEAN, and the ability to apply this knowledge in practice.
* Japanese Language Proficiency: N1.
### Preferred Skills
* Understanding of cosmetics markets and business practices in various countries.
* Business-level proficiency in Taiwanese (Traditional Chinese), Chinese, and Korean.
### Working Hours
* Monday to Thursday: 9 hours of work and 1 hour break between 6:00 and 22:00.
* Friday: 4 hours of work between 6:00 and 13:00.
* Full-time office attendance; Monthly variable working hours system.