Job Description

Regulatory/ Product Specialist

- Responsible for obtaining authorisation of medicines for pharmaceutical industry.

- Responsible for the preparation and documentation of regulatory submissions to government agencies.

- Works on problems of diverse scope where analysis of situations or data requires a review of identifiable factors.

- Exercises judgement within generally defined practices and policies in selecting methods and techniques for obtaining solutions.

- Normally receives instructions on routine work, general instructions on new assignments.

- May provide leadership by assigning work and resolving complex problems.

- With direction, develop plans for regulatory strategies.

- Participates in project team meetings and provides regulatory advice. Seeks solutions and alternatives to problems and issues.

- Prepares regulatory documents for regional submissions. Acquires information from appropriate technical groups and project personnel which addresses performance of diagnostic reagents, instruments, and software.

- Assures adequate documentation exists for product claims and directs timely review of regulatory documents.

- Acts as a liaison for international divisions by tracking requests for information and monitoring international laws.

- Provides product performance data as requested by international personnel and other corporate groups.

- Monitors HSA and other agency laws and regulations and provides recommendations and assistance to ensure company compliance.

- Direct certification application activities including sending and tracking certification letters. Maintain tracking log and supply global registration requests.

- Provides metrics for regulatory management reporting and helps to identify areas for further monitoring for global product development system (GPDS) improvements.

- Track global registration status for project teams and new products. Log, track, and prepare report from eGPS system.

- Provide Product Training for new Medical Representative.

Performs other related duties and assignments as required.