Deskripsi Pekerjaan
Are you a detail-oriented professional looking to shape the future of pharmacy compliance? Join Impexcos Co. as a Regulatory Pharmacist and lead regulatory excellence in a dynamic healthcare environment. In this pivotal role, you will oversee the regulatory lifecycle of our pharmaceutical products, ensuring full compliance with local and international standards.
We are seeking a strategic thinker to manage product registrations, prepare complex dossiers, and navigate the regulatory landscape with precision. If you are passionate about professional growth and maintaining the highest standards of quality assurance, this is the opportunity for you.
Tanggung Jawab
- Manage the end-to-end regulatory lifecycle of pharmaceutical products, including product registration and licensing with the Bureau of Food and Drugs (BFAD).
- Prepare and submit comprehensive regulatory dossiers, including CMC data, labeling, and promotional materials.
- Monitor changes in local and international regulatory laws and update internal compliance policies accordingly.
- Coordinate closely with R&D, Quality Assurance, and Manufacturing teams to ensure documentation accuracy and timely submissions.
- Act as the primary point of contact for regulatory authorities, addressing inquiries and resolving compliance issues efficiently.
- Maintain an organized digital and physical filing system for all regulatory documents and correspondence.
Kualifikasi
- Bachelor of Science in Pharmacy (RPh) licensed to practice in the Philippines.
- Minimum of 2-3 years of experience in Regulatory Affairs, Quality Assurance, or Pharmacy Compliance.
- Strong working knowledge of Philippine FDA regulations, Pharmacopeia, and Good Manufacturing Practices (GMP).
- Excellent written and verbal communication skills with the ability to interpret complex regulatory texts.
- High level of attention to detail and organizational skills essential for managing multiple deadlines.
- Proficiency in Microsoft Office Suite and regulatory management software.
- Ability to thrive in a fast-paced environment and collaborate effectively across cross-functional teams.