Regulatory Affairs Pharmacist

Role Description

This is a full-time on-site role for a Regulatory Affairs Pharmacist at DEEL CORPORATION located in Alabang, Muntinlupa City. The Regulatory Affairs Pharmacist will be responsible for ensuring regulatory compliance, understanding and implementing regulatory requirements, managing regulatory affairs, and utilizing pharmacy knowledge to support the company's operations.

Tasks

• Monitor the validity of License to Operate, Certificate of Product Registration, Certificate of Product Notification and all legal documents.
• Maintain and process the product registration and renewal of License to Operate, Certificate of Product Registration, Certificate of Product Notification and other related documents.
• Update all necessary documents for product registration and for government transactions.
• Coordinate with our principals for the required documents to be submitted to FDA.
• Communicate with the Marketing and Advertising team to ensure strict compliance with the guidelines and policies of the regulatory agency.
• Compile and maintain complete technical data of each product.
• Prepare, evaluate and submit documents for product registration to FDA.
• Monitor and follow up continuously on the application status of products filed for registration.
• Perform proper and timely documentation and submission of required technical information of the products to FDA for appropriate processing of certificates.
• Ensure that the company complies with the applicable government rules and regulations.
• Be updated on new regulations or changes.
• Facilitate back-end support team within its respective department (Sales & Administrative).
• Assure all inventory stocks are in a good storage area and properly labelled.
• Assist in the preparation of necessary documents for government transactions.
• Attend seminars and training to broaden regulatory knowledge.
• Provide relevant information to sales personnel regarding new updates, advisory and guidelines related to FDA and DOH concerns.
• Handle customer complaints, product return, product recall and counterfeit products. Provide necessary actions to resolve existing issues and problems.
• Maintain the availability and inventory of stocks.
• Maintain a good distribution record and good storage of the product.

Qualifications

• Degree in Pharmacy, with PRC License
• Experience in Regulatory Affairs and Pharmacy
• Excellent Computer Skills (Excel, Word, PowerPoint, etc.)
• Excellent communication skills, organizational and technical skills
• Attention to detail and analytical skills
• Ability to interpret and implement regulatory guidelines

Job Type: Full-time

Pay: From Php30,000.00 per month

Benefits:

• Company events
• Promotion to permanent employee

Application Question(s):

• Are you comfortable working in an on-site setting?
• Are you comfortable commuting to this job's location (Alabang, Muntinlupa City)?

License/Certification:

• PRC License (Required)

Work Location: In person