Regulatory Affairs coordinator - la croesus pharma incLakpue Drug Inc

Description
I.JOB SUMMARY
Responsible for the coordination, preparation, and archiving of regulatory submissions to the Food and Drug Administration and related amendments and supplements associated with existing applications.
II.DUTIES AND RESPONSIBILITIES
1. Reports directly to the Regulatory Affairs Supervisor
2. Assist in the preparation and timely submission of regulatory documents;
3. Prepares, maintains, update, and audit product profiles and other regulatory document files;
4.Coordinates with concerned departments regarding documents needed in the preparation of product dossiers;
5.Preparation of documents for Batching, NOD, Renewal Drug, Food, Hazardous;
6.Organize and maintain tracking of Regulatory affairs documents and communication on a regular basis;
7.Ensures all regulatory files are prepared for off-site storage in accordance with FDA and other applicable regulatory guidelines;
8. Maintains master product files and location lists to be used for regulatory purposes;
9. Track expiration and retrieve current documentation for renewal registration and compliance;
10.Preparation of documents needed for batching, NOD's, renewal of drug, food, hazardous and product registration;
11. Ensures cleanliness and good housekeeping within the Regulatory area;
12. Participates in the strick implementation of cGMP;
13. Performs other tasks, which may be assigned from time to time.
III. QUALIFICATIONS
1.Graduate of BS Pharmacy, a professional license is an advantage.
2. Good interpersonal, oral, and written communication skills.
3. Must have the ability to work on minimal supervision once trained.
4. Computer Literate, proficient in MS Word, Excel, and PowerPoint.
5.cGMP oriented.
6. Must be willing to work in Binan Laguna
Requirements
Minimum education level: Bachelor ́s Degree
Language(s): English
Availability for travel: No
Availability for change of residence: No

Laguna, Calabarzon ·  Today, 05:37 PM
Work type
Full Time