Deskripsi Pekerjaan
Join Brady Pharma Inc. as a Regulatory Affairs Associate and make a significant impact in the pharmaceutical industry. We are seeking a dedicated and detail-oriented Licensed Pharmacist to oversee our regulatory compliance and ensure the successful registration of our products in the Philippines.
In this pivotal role, you will manage the preparation and submission of regulatory dossiers to the Bureau of Food and Drugs (BFAD) / FDA. You will be responsible for maintaining up-to-date product registrations, monitoring changes in regulatory laws, and coordinating with cross-functional teams to gather technical data. If you possess a strong background in pharmaceutical regulations and a commitment to excellence, this is your opportunity to grow your career with a leading healthcare company.
Tanggung Jawab
- Prepare and submit comprehensive regulatory dossiers and applications to the FDA/BFAD for new product registrations.
- Monitor and analyze changes in local and international pharmaceutical regulations to ensure compliance.
- Maintain and organize regulatory files, product registrations, and correspondence.
- Liaise with health authorities to address inquiries and resolve regulatory issues efficiently.
- Coordinate with R&D, Quality Assurance, and Marketing teams to compile necessary documentation for submissions.
- Prepare and submit renewal applications and amendments for existing product licenses.
- Ensure all regulatory activities are completed within strict deadlines.
Kualifikasi
- Must be a Licensed Pharmacist (RPh) with valid license to practice in the Philippines.
- Bachelor’s degree in Pharmacy with a strong academic background.
- Minimum of 2-4 years of experience in Regulatory Affairs, Quality Assurance, or related pharmaceutical functions.
- In-depth knowledge of FDA regulations, Good Manufacturing Practices (GMP), and pharmaceutical guidelines.
- Excellent written and verbal communication skills in English.
- Strong organizational skills and the ability to manage multiple regulatory tasks simultaneously.
- Proficiency in MS Office and regulatory database management systems.