Deskripsi Pekerjaan
Join Vita Shopindo as a Regulatory & Training Specialist and become a vital guardian of compliance excellence in Indonesia's health and medical sector. This pivotal role empowers you to navigate the complex landscape of product registration, licensing, and regulatory adherence while shaping organizational knowledge through targeted training initiatives. You'll ensure Vita Shopindo's products meet stringent BPOM standards, safeguarding public health while driving operational efficiency.
As our Regulatory & Training Specialist, you'll be the bridge between regulatory requirements and practical implementation. Your expertise will directly impact product lifecycle management from registration to post-market surveillance. This position offers the unique opportunity to develop comprehensive training programs that empower teams to maintain compliance excellence across all departments. If you're passionate about regulatory precision and knowledge transfer, this role provides a platform to make meaningful contributions to healthcare quality standards.
Tanggung Jawab
- Manage end-to-end product registration and licensing processes in strict BPOM compliance
- Develop and implement regulatory training programs for staff at all levels
- Monitor regulatory landscape changes and update internal protocols accordingly
- Prepare and submit comprehensive documentation to regulatory authorities
- Conduct internal compliance audits and corrective action planning
- Collaborate with R&D and production teams on regulatory requirements
- Maintain accurate regulatory documentation and training records
- Represent the company in regulatory consultations and industry forums
Kualifikasi
- Bachelor's degree in Pharmacy, Biology, Chemistry, or related field
- Minimum 3 years regulatory affairs experience in health/medical sector
- Deep knowledge of BPOM regulations and Indonesian compliance standards
- Certification in Regulatory Affairs (RAC) or equivalent preferred
- Exceptional training development and presentation skills
- Strong analytical and documentation abilities
- Proficiency in regulatory management software and MS Office Suite
- Fluent in Bahasa Indonesia and English (written and verbal)