Regulatory Affairs and Quality Manager

Manila Permanent
  • Global healthcare specializing in ethical pharma & medical devices
  • Billion dollar conglomerate

About Our Client

20 years of multinational expertise in the ethical pharmaceutical and medical device sector.

Job Description

Regulatory Affairs

  • Assesses regulatory risks, formulates and implements registration strategies.
  • Negotiates with FDA for accelerated approval of submitted application, while ensuring compliance with relevant regulations.
  • Provides accurate regulatory information and product registration status to global and regional offices.
  • Ensures maintenance of local and corporate database for timely tracking of status of all registrations.
  • Keeps abreast with changes in regulations of government agencies and industry trends.
  • Manages product quality assurance systems according to company standards.
  • Responsible for obtaining permits for the importation and sales of narcotic substances.
  • Manages clinical trials in coordination with corporate and regional medical affairs.
  • Reviews and checks pertinent marketing materials used for promotion and ensures compliance with local policies on advertisement and promotion of registered products.
  • Provides timely and accurate product development and registration timeline and inputs to Finance and Marketing in the preparation forecasts, budget and strategy.



Quality Management

  • Integrates the corporate Quality Management System of the company.
  • Reports QA issues to the management committee.
  • Reviews the effectiveness of the QM system by conducting internal audit.
  • Follows up and implements corrective actions.
  • Endeavors contintuous improvement of the QMS.



*Additional responsibilities would include complaints and national safety.

The Successful Applicant

  • B.S. in Pharmacy
  • Licensed Pharmacist
  • 10 years of experience in liaising and dealing with FDA and other regulatory government bodies.
  • 2 years experience in QMS including internal/external audit and document control process.
  • Extensive knowledge on the international and national regulatory laws on pharmaceutical, medical devices and food products.
  • Basic knowledge of ISO 9001 Quality Management System

What's on Offer

  • Flexible work arrangements
  • Competitive compensation and benefits package
  • Stability and progressive career
Contact
Eds Enslie
Quote job ref
4211944
Phone number
+63 02 7795 2813

Job summary

Function
Life Sciences
Sub Sector
Regulatory Affairs
What is your area of specialisation?
Healthcare / Pharmaceutical
Location
Manila
Job Type
Permanent
Consultant name
Eds Enslie
Consultant contact
+63 02 7795 2813
Job Reference
4211944