job description
Join DKSH, a leading market expansion services provider, as an Executive Regulatory Affairs in Bali. At DKSH, we empower businesses to thrive in Asia while fostering a culture of accountability, innovation, and excellence. In this role, you will play a pivotal part in ensuring compliance with local and international regulations, driving strategic initiatives, and supporting our mission to enable growth and performance in the healthcare and medical sectors.
Based in the vibrant and culturally rich region of Bali, you will collaborate with cross-functional teams to navigate regulatory landscapes, streamline approval processes, and contribute to the success of our clients and partners. This is an exceptional opportunity for a detail-oriented professional with a passion for regulatory affairs and a desire to make a meaningful impact in a dynamic, global organization.
Responsibility
- Oversee and manage regulatory submissions, ensuring compliance with local and international healthcare regulations.
- Liaise with government agencies, regulatory bodies, and internal stakeholders to facilitate product registrations and approvals.
- Develop and implement regulatory strategies to support business objectives and market expansion initiatives.
- Monitor and analyze regulatory trends, providing insights and recommendations to senior management.
- Prepare and review regulatory documentation, including dossiers, labels, and marketing materials.
- Collaborate with cross-functional teams to ensure adherence to regulatory requirements throughout the product lifecycle.
- Conduct regulatory risk assessments and propose mitigation strategies.
- Provide training and guidance to internal teams on regulatory compliance and best practices.
Qualifications
- Bachelor's degree in Pharmacy, Life Sciences, or a related field. Advanced degree preferred.
- Minimum of 3-5 years of experience in regulatory affairs, preferably in the healthcare or pharmaceutical industry.
- In-depth knowledge of Indonesian and international regulatory requirements and guidelines.
- Strong analytical, problem-solving, and project management skills.
- Excellent communication and interpersonal skills, with the ability to engage effectively with stakeholders at all levels.
- Proficient in English and Bahasa Indonesia, both written and verbal.
- Detail-oriented with a high degree of accuracy and organizational skills.
- Ability to work independently and collaboratively in a fast-paced, multicultural environment.