Deskripsi Pekerjaan
Are you a detail-oriented professional with a passion for public health and regulatory compliance? Health Wellness lifestyle, Inc. is seeking a dedicated Regulatory Pharmacist to join our dynamic team in Pasig City, Metro Manila. In this pivotal role, you will ensure that our pharmaceutical products meet all local and international regulatory requirements, safeguarding patient safety and maintaining our reputation for excellence. We are looking for a candidate who thrives in a fast-paced environment and possesses a strong understanding of the pharmaceutical regulatory landscape in the Philippines. If you are ready to make a tangible impact on the healthcare industry, we encourage you to apply.
Tanggung Jawab
- Oversee and manage the registration and licensing of pharmaceutical products with the relevant government regulatory bodies.
- Conduct thorough reviews of dossiers, product specifications, and labeling to ensure compliance with FDA regulations and industry standards.
- Monitor and interpret changes in local pharmaceutical laws and international regulations to maintain an up-to-date compliance status.
- Prepare, compile, and submit necessary documentation for product approvals, renewals, and amendments.
- Collaborate with cross-functional teams, including quality assurance and manufacturing, to address compliance issues and implement corrective actions.
- Maintain accurate and organized records of all regulatory submissions and correspondence.
Kualifikasi
- Licensed Pharmacist with a valid certificate of registration issued by the Professional Regulation Commission (PRC).
- Minimum of 2-3 years of experience in regulatory affairs or a similar role within the pharmaceutical or healthcare sector.
- In-depth knowledge of the Philippine FDA regulations, including the Food and Drug Administration Act of 1972 (R.A. 3720).
- Strong analytical and problem-solving skills with keen attention to detail.
- Excellent written and verbal communication skills, with the ability to interact effectively with government agencies.
- Proficiency in Microsoft Office Suite and regulatory database management systems.