Deskripsi Pekerjaan
Are you a dedicated Pharmacist looking to make an impact in the pharmaceutical industry? Cyden Medicale Trading Inc. is seeking a detail-oriented and proactive Regulatory Pharmacist to join our team based in Urdaneta City, Pangasinan. In this pivotal role, you will be the guardian of our regulatory compliance, ensuring that all our pharmaceutical products meet the stringent standards set by the Food and Drug Administration (FDA) and other governing bodies.
You will work closely with cross-functional teams to manage product registrations, license renewals, and quality assurance documentation. The ideal candidate is someone who thrives on precision, stays updated with ever-evolving pharmaceutical regulations, and is committed to upholding the highest standards of safety and efficacy for our patients.
Tanggung Jawab
- Manage and oversee the preparation, submission, and follow-up of FDA applications for initial product registration, variations, and renewals.
- Ensure that all pharmaceutical operations comply with current Good Manufacturing Practices (cGMP) and Good Distribution Practices (GDP).
- Maintain and organize comprehensive regulatory documentation, including technical files, labeling, and promotional materials.
- Coordinate with internal departments to address regulatory queries and ensure timely responses to government agencies.
- Monitor changes in local pharmaceutical regulations and communicate impact assessments to management.
- Conduct regular internal audits to ensure ongoing compliance with company policies and regulatory requirements.
- Liaise with the FDA and other health authorities to foster professional relationships and resolve compliance issues effectively.
Kualifikasi
- Must be a Licensed Pharmacist (PRC License holder).
- Preferably with at least 1-2 years of experience in regulatory affairs, though high-potential fresh graduates are welcome to apply.
- In-depth knowledge of FDA Philippines regulations and administrative orders.
- Strong technical writing skills for regulatory submissions and SOP development.
- Excellent attention to detail and ability to interpret complex legal and medical documentation.
- Proven ability to work independently while managing multiple deadlines in a fast-paced environment.
- Proficiency in MS Office Suite and data management systems.
- Willingness to be based in Urdaneta City, Pangasinan.