job description
Join Yanling Natural Hygiene as an International Regulatory Affairs Executive and play a pivotal role in expanding our global footprint in the healthcare and medical industry. This position offers a unique opportunity to shape regulatory strategies, ensure compliance, and drive business growth in international markets.
Based in the vibrant regions of Bali, you will collaborate with cross-functional teams to navigate complex regulatory landscapes, identify emerging market trends, and provide expert guidance on product registrations and certifications. Your expertise will be instrumental in maintaining our commitment to quality, safety, and innovation while fostering strong relationships with regulatory authorities worldwide.
If you are a detail-oriented professional with a passion for regulatory affairs and a drive to make a global impact, we invite you to apply and become part of our dynamic team.
Responsibility
- Develop and implement regulatory strategies to support international market expansion and product launches.
- Monitor and interpret global regulatory requirements, ensuring compliance with local and international standards.
- Prepare and submit regulatory documentation for product registrations, renewals, and variations.
- Liaise with regulatory authorities, distributors, and internal stakeholders to facilitate approvals and resolve compliance issues.
- Conduct regulatory intelligence activities to identify trends, risks, and opportunities in target markets.
- Provide training and guidance to internal teams on regulatory policies, procedures, and best practices.
- Collaborate with R&D, Quality Assurance, and Marketing teams to ensure regulatory considerations are integrated into product development and marketing strategies.
- Maintain and update regulatory databases, ensuring accurate and up-to-date information is readily available.
Qualifications
- Bachelor's degree in Pharmacy, Life Sciences, Chemistry, or a related field. Advanced degree preferred.
- Minimum of 3-5 years of experience in regulatory affairs, preferably in the healthcare, medical device, or pharmaceutical industry.
- Strong knowledge of international regulatory frameworks, including ASEAN, FDA, EU, and other relevant guidelines.
- Proven experience in preparing and submitting regulatory dossiers for product registrations.
- Excellent communication and negotiation skills, with the ability to interact effectively with regulatory authorities and internal stakeholders.
- Detail-oriented with strong analytical and problem-solving skills.
- Ability to work independently and manage multiple projects in a fast-paced environment.
- Proficiency in English; additional languages are a plus.