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Regulatory Pharmacist

PHP 30,000 per month

Fairmode Inc.

Established in 2011 | 11-50 employees
226 Swigert Street, Parañaque, Metro Manila
Posted on : October 02, 2020
Job ID : 366517

Details

FAIRMODE INC.
 
Is currently looking for:
 
REGULATORY PHARMACIST
 
Job description:
  • Goal oriented  capable  to work Independently  with a good sense of self-initiative and decision making 
  • Should be familiar with all aspects of the Products registration/renewal for Generic Pharma/ food supplements/ Nutraceuticals  /Cosmetic and medical devices.
  • Perform activities for getting new registrations and maintaining registrations as per business goals.
  • Ensure follow-up with the Philippine FDA on files under review and ensure regulatory compliance within the required time frame.
  • Having the Knowledge of overseas Manufacturing facility Inspection / Audit will be an added advantage  
  • Capability to work with regulatory agencies / as well as suppliers/principals regulatory departments and willingness to travel outside the country.
  • Familiarity to evaluate all documents pertaining to product registration, communication/ follow up  with the counterpart for required documents/details    
  • Builds and maintains good relations with internal and external stakeholders.
  • Proficiency in compiling regulatory submission dossiers according to local Philippines FDA regulations.
  • Proficiency in handling labeling requirements.
  • proficiency in creating/reviewing packaging layouts in line with existing standards set by FDA
  • Should know the regulatory guidelines to be followed prior and upon the importation of highly regulated Products  
  • Support Regulatory Affairs team for all GXP related issues including audits.
  • Proper use of internal regulatory systems.
  • Know and understand relevant regulatory rules, guidelines, and procedures within relevant therapeutic areas and devices.
Job Type / Category
  • Working time is from 8 am -5 pm OR 9 am -6 pm.
Required Education, Skills, and Qualifications
  • Bachelor degree in Pharmacy.
  • Good communication and interpersonal skills
  • Proficient in MS Office Applications
  • Ability to meet the deadlines 
  • Certified Pharmacist with QPIRA training Certificate is an advantage
  • Minimum 3-4 years or more  Regulatory experience in the Pharmaceutical industry
Job Type: Full-time
 
Salary: PHP 30,000/Month
 
Location: Moonwalk ( Near Multinational Paranaque )


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