26/01/2021
DESCRIPTION:
Wholesale drug distributors are a link between manufacturers and pharmacists. Their role is to ensure prescription medications are delivered safely and efficiently every day to thousands of health care practitioners and pharmacies nationwide. Pharmaceutical distributors purchase prescription medicines and other medical products directly from pharmaceutical manufacturers for storage in warehouses and distribution centers across the country. State and federally licensed pharmacies, hospitals and healthcare providers place orders with distributors for the medicines and products they need, and the distributors process and deliver the orders daily.
RESPONSIBILITIES :
1.Support in the operational and/or administrative preparation and submission of products for renewal and New Product Development (NPD) applications, new indications, new presentations, new manufacturing site and variations to FDA for drug, food supplements, cosmetics, medical devices and other products
2.Handle FDA applications, permit applications and approvals, and other regulatory activities
3.Update and maintain regulatory database, files and tracking sheets and the archiving of all relevant documentation in the appropriate system.
4.Interacts with local team to obtain information required for submission to FDA and provide regulatory documents and/or information to support the business.
5.Ensure compliance with local regulations and corporate policies and procedures.
6.Acquire and expand knowledge in local regulations related to regulatory affairs.
7.Where applicable, may be involved in other regulatory projects from local, regional and/or Global Regulatory Affairs from time to time
8.Ensure that medicines/drugs received are FDA-approved prescription drugs, that all medicines/drugs are purchased from FDA-registered suppliers, and that customers/clients distributed are FDA-registered establishments
9.Plans and implements or maintains procedure for proper disposal of expired drugs/ medicine to ensure safety
10.Ensure that all products are in good storage condition
11.Supervise inventory management
12.Ensure smooth routine operations for distribution
13.Inspect and double check for the following signs that a product may be unsafe, ineffective, or fake.
QUALIFICATIONS/SKILLS:
- 18 - 30 years old
- Graduate of Bachelor of Science in Pharmacy or Industrial Pharmacy
- Passed the Professional Pharmacy Licensure Examination
- Working experience related to Regulatory Affairs is an advantage.
- Ability to focus on multiple issues at one time, ability to organize, prioritize and work under time pressure.
- Computer literate.
- Good time management skills
- Good document organization skills
- Eagerness to learn
- Has good work ethic
- Must be self-motivated
