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REGULATORY AFFAIRS SPECIALIST | BGC, TAGUIG

Job Category:

Healthcare / Science

Job Level:

Professional

Open Date:

12-Oct-2020

Location:

TAGUIG CITY

Close date:

31-Oct-2020

Client Industry:

PHARMACEUTICAL

Job Description and Qualification:

Qualifications

  • Bachelor degree in Pharmacy or Industrial Pharmacy
  • A duly licensed pharmacist by the Professional Regulation Commission
  • Minimum 6-8 of Regulatory experience in the Pharmaceutical industry
  • Having a PhFDA Certified as Qualified Person in Industry Regulatory Affairs (QPIRA) would be an advantage.
  • Advanced computer skills and readiness to travel
  • Excellent command of written and spoken English and native speaker of local language
  • Can start Immediately
  • Open to do field work
  • Will temporarily work from home but should be ready to report on site as needed
  • Strong communication and organizational skills
  • Strong customer service and interaction skills

Responsibilities

  • Conduct regular visits to the Philippine Food and Drug Application to follow-up all regulatory processes
  • 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
  • Capability to work with regulatory agencies across southeast Asia and willingness to travel across southeast Asia
  • Builds and maintains good relations with internal and external stakeholders
  • Proficiency in compiling regulatory submission dossiers according to local Philippines FDA regulations and other southeast Asian country specific health authority requirements
  • Proficiency in handling labelling requirements
  • 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.

Salary:

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