- 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.
- 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.
- 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