We are seeking an experienced International Regulatory Affairs professional to manage product registration and regulatory compliance in overseas markets.
This position will act as the Company's key regulatory representative, coordinating with foreign authorities, local regulatory agencies, distributors, consultants, and internal teams to ensure that products are successfully registered and legally marketed in each target country.
Key Responsibilities:
- Manage end-to-end product registration, renewal, amendment, and regulatory approval processes in international markets.
- Research regulatory requirements, product classifications, registration procedures, timelines, and fees for each target country.
- Prepare, review, and coordinate regulatory dossiers and supporting technical documents.
- Liaise with overseas regulatory authorities, local registration agents, distributors, consultants, and laboratories.
- Follow up on registration applications, authority inquiries, and additional document requirements until approval is obtained.
- Review product formulations, specifications, labels, packaging, claims, and marketing materials for regulatory compliance.
- Assess regulatory feasibility and risks for new products and new market-entry projects.
- Maintain accurate records of registration status, approval conditions, expiry dates, and renewal schedules.
- Provide regulatory advice and support to International Sales, Business Development, Marketing, R&D, Quality Assurance, and Supply Chain teams.
- Manage external regulatory agencies and ensure registration activities are completed within the agreed timeline and budget.
Qualifications:
- Bachelor's degree or higher in Pharmacy, Chemistry, Biology, Food Science, Agricultural Science, Regulatory Science, or a related field.
- At least 5 years of experience in Regulatory Affairs, international product registration, or a regulatory consulting agency.
- Proven experience in registering products in multiple countries.
- Experience with household insecticides, biocides, cleaning products, public health products, agricultural products, food and beverage, or related consumer products is preferred.
- Strong knowledge of regulatory dossier preparation, product classification, labeling, and compliance requirements.
- Excellent written and spoken English.
- Able to work independently and coordinate effectively with international stakeholders.
- Foreign nationality or international regulatory experience is highly preferred.
