Deskripsi Pekerjaan
Join Medisindo Bahana, a leading healthcare company, as a Regulatory Affairs Manager and take your career to new heights. We are seeking an experienced professional to navigate the complex regulatory landscape and ensure compliance with healthcare regulations. As a key member of our team, you will play a crucial role in bringing innovative healthcare solutions to market while maintaining the highest standards of quality and safety.
At Medisindo Bahana, we value professional growth and offer competitive benefits to support your career journey. You'll have the opportunity to work with a dynamic team of experts and contribute to the advancement of healthcare in Indonesia and beyond. Our commitment to excellence and innovation makes us an ideal workplace for passionate regulatory affairs professionals.
If you are ready to make a significant impact in the healthcare industry and thrive in a challenging yet rewarding environment, we encourage you to apply for this exciting opportunity.
Tanggung Jawab
- Develop and implement regulatory strategies for healthcare products and services
- Ensure compliance with local, national, and international healthcare regulations
- Prepare and submit regulatory documentation to health authorities
- Monitor and interpret changes in healthcare regulations and advise the organization
- Liaise with regulatory agencies and represent the company in regulatory meetings
- Coordinate with internal teams to ensure regulatory requirements are met throughout product lifecycle
- Manage regulatory submissions and approvals for new products and product modifications
- Maintain up-to-date knowledge of regulatory changes and industry best practices
Kualifikasi
- Bachelor's degree in Pharmacy, Medicine, Life Sciences, or related field
- Minimum 5 years of experience in regulatory affairs, preferably in healthcare industry
- Deep knowledge of healthcare regulations and compliance requirements in Indonesia
- Strong understanding of international regulatory frameworks (FDA, EMA, etc.)
- Excellent written and verbal communication skills in both English and Bahasa Indonesia
- Proven ability to manage complex regulatory projects and meet deadlines
- Attention to detail with strong analytical and problem-solving skills
- Experience with regulatory documentation and submission processes