Entry-Level Regulatory Affairs Executive - Medical Innovation Ventures

Launch your career in Regulatory Affairs with Medical Innovation Ventures (Mediven), a pioneer in cutting-edge healthcare solutions. As an Entry-Level Regulatory Affairs Executive, you’ll play a pivotal role in ensuring compliance with global and regional regulations, guiding Mediven’s innovative products through the complex regulatory landscape in Indonesia and beyond. In Denpasar, Bali, you’ll work closely with a dynamic team to support Mediven’s mission to revolutionize healthcare.

As an Entry-Level Regulatory Affairs Executive, you’ll be responsible for assisting in the preparation and submission of regulatory documents, such as Investigational New Drug (IND) applications, Marketing Authorization Applications (MAA), and other related submissions. You’ll also conduct research and analysis on regulatory requirements, keeping Mediven informed of any changes or updates. This role offers a unique opportunity to grow within a forward-thinking company that values innovation and compliance.

📋 Tanggung Jawab Pekerjaan

• Assist in the preparation and submission of regulatory documents, including IND applications, MAA, and other related submissions.
• Conduct research and analysis on regulatory requirements, keeping Mediven informed of any changes or updates.
• Support the team in maintaining accurate and up-to-date regulatory databases and documentation.
• Assist in the coordination of regulatory meetings and interactions with regulatory authorities.
• Provide administrative support to the Regulatory Affairs team, including document management and filing.
• Assist in the development and implementation of regulatory strategies and plans.
• Support the team in the preparation of regulatory reports and presentations.
• Assist in the training and development of junior staff in regulatory affairs.

🎓 Kualifikasi & Syarat

• Bachelor’s degree in Pharmacy, Life Sciences, or a related field.
• Familiarity with regulatory requirements in Indonesia and other key markets.
• Basic understanding of regulatory documentation and submission processes.
• Excellent communication and interpersonal skills.
• Strong organizational and time management skills.
• Proficiency in English, both written and spoken.
• Ability to work independently and as part of a team.
• Willingness to learn and adapt to new challenges.

🛠️ Keahlian

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