Deskripsi Pekerjaan
Join Hyphens Pharma, a leading healthcare organization, as a Regulatory Affairs Executive and play a crucial role in ensuring our products comply with local and international regulations. In this position, you will be responsible for the entire product registration lifecycle, from initial submission to final approval. You will act as the primary liaison between our company and regulatory authorities, ensuring timely communication and adherence to all regulatory requirements. Your expertise will be vital in maintaining our regulatory databases, ensuring accuracy and completeness of all documentation, and staying updated on the latest regulatory changes that may impact our products. This role requires a meticulous approach, excellent communication skills, and a deep understanding of the pharmaceutical industry's regulatory landscape. If you are passionate about regulatory compliance and looking to advance your career in a dynamic healthcare environment, we encourage you to apply for this exciting opportunity at Hyphens Pharma.
Tanggung Jawab
- Manage the complete product registration process for pharmaceutical products in compliance with local and international regulations
- Liaise with regulatory authorities including the Ministry of Health and other relevant agencies
- Maintain and update regulatory databases to ensure accuracy and completeness of documentation
- Monitor and interpret changes in regulatory requirements and communicate impacts to internal stakeholders
- Prepare and submit regulatory documentation including dossiers, variations, and renewals
- Coordinate with cross-functional teams including R&D, Quality Assurance, and Marketing to ensure regulatory compliance
- Conduct regulatory intelligence gathering to stay informed about industry developments and best practices
Kualifikasi
- Bachelor's degree in Pharmacy, Life Sciences, Chemistry, or related field; Master's degree is preferred
- Minimum of 2-3 years of experience in regulatory affairs within the pharmaceutical or healthcare industry
- Strong knowledge of local and international regulatory requirements and guidelines
- Excellent communication and interpersonal skills with the ability to liaise effectively with regulatory authorities
- Attention to detail with the ability to manage complex documentation and processes
- Proficiency in regulatory databases and documentation management systems
- Ability to work independently and as part of a team in a fast-paced environment