Job qualication
- Graduate of BS in Pharmacy and Licensed Pharmacist
Preferably with at least 1 year experience in the field- Strong sense of responsibility
Preferably with 3 to 4 years experience as a Pharmacist and as a Regulatory Pharmacist in a pharmaceutical distributor company or other distribution and wholesale company.
Core Function
- To monitor and comply to all the requirements and standards set by the FDA, IPO, GS1,PDEA, EDPMS and, PhilGEPS, The incumbent is also responsible in double checking and safe keeping mother files of CPR, COD, CGMP for bidding. He/she is involved in researching, applications and monitoring of exclusive products.
Primary Function
- Represents the company in the Food and Drugs Administration (FDA) through the professional license in order to secure a License to Operate (LTO) to engage in any of the activities of a drug establishment.
Prepares all the requirements and takes charge in the initial and renewal registration of all local/imported products.- Keeps track of any change in the requirement by the FDA with regards to registration and coordinates them with the supplier and management.
To manage, monitor and evaluate all day-to-day activities in the SCD-PTD Division. The incumbent should direct and oversee all areas in the Procurement and Technical Division.
Secondary Tasks
- Prepares all the requirements and takes charge in the initial and renewal registration of all local/imported products.
Involved in the product research and development of products being registered to suppliers and creates a document with the intention to apply for new products and coordinates all the files related to the registration to suppliers including its contract, packaging designs, and prescribed fees.- Follows up with FDA the status of application for product registration and other licenses.
Attends seminars and trainings to further knowledge and enables renewal of professional license for company representation.
- Communicates with the supplier technical requirements as regards to registration of products and periodically reports the status after registration,
Requests for an assessment or pre-evaluation of new products for its categorical classification.- Maintains a systematic file of product registrations, certificate of good manufacturing practice, distributor agreements/certificates and monitors its expiration dates.
Files and prepares all necessary documents/requirements in the renewal of License to Operate.
- Requests for inspection by the FDA, and accommodates the visiting inspectors prior to license renewal and/or inclusion of supplier and products in the LTO.
Keeps track of any change in the requirement by the FDA with regards to registration and coordinates them with the supplier and management.- Handles the complaints of all products from clients and facilitates the recall in coordination with other departments.
Prepares all the documents needed by the Sales and Marketing force and Customer Sales Representatives such as certificate of product registration, certificate of good manufacturing practice, certificate of analysis and batch notification.
- Prepares all documents required by government biddings and other transactions as certificate of product registration, certificate of good manufacturing practice, certificate of analysis and batch notification.
Performs other job related duties and responsibilities as determined by immediate head and/or performs job related tasks that may arise as needed by the company including participation in company events/activities.- Provide assistance to TWG with regards to technical-related concerns, issues, and reports as per requested by different agencies per Company.
Job Type: Full-time
Pay: From Php23,- 00 per month
Benefits: - Opportunities for promotion
Paid training
Schedule:
Day shift
Supplemental pay types: Overtime pay
