Regulatory Affairs Officer

GENERIKA DRUGSTORE
National Capital Reg

Job Description

SUMMARY OF RESPONSIBILITIES
1. Directly coordinates with the Generika stores, and prepare all requirements for
license-to-operate (LTO) application with FDA.
2. Prepare submissions of license variations and renewals to strict deadlines.
3. Develops and writes clear arguments and explanations for new licenses and
license renewals.
4. Monitors and sets timelines for license variations and renewal approvals of all
stores (GENERIKA DRUGSTORE) and distribution centers (ACTIMED).
5. Provides a monthly status report of the LTOs that may include initial, renewal and on-going applications.
6. Negotiates with regulatory authorities for marketing authorization (LTO).
7. Consolidates and checks of requirements for promo application with FDA
8. Assists in the preparation of Generika Drugstores COS’ CAPA compliance to FDA.
9. Monitors the replenishments of FDA compliance documents and supplies (i.e.
graduated cylinder, mortar and pestle, etc.) to new and existing stores.
10. Keeps up to date with national and international legislation, guidelines and
customer practices.
11. Processes product sample assay of House Brands with FDA approved laboratories
(CEDRES, UP, etc.).
12. Regularly updates of Generika Gamot Guide.
JOB REQUIREMENTS
EDUCATION AND EXPERIENCE
  • Bachelors/College Degree in Pharmacy, Registered Licensed Pharmacist
  • At Least 5 years relevant experience in the pharmaceutical industry or drugstore
  • operations
  • Experience in regulatory work with government agencies particularly with FDA,DOH, etc.

Specialization: Pharmacy
Hiring Company

GENERIKA DRUGSTORE

Generika Drugstore is the pioneer in the retail of generic medicines in the country established in 2003. Generika Drugstore provides access to quality affordable generic medicines specially to underserved communities.... (More)

See all Careers and Jobs at GENERIKA DRUGSTORE
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