Regional Regulatory Affairs Manager

[Megan Tan]

Responsibilities:
- Provide strategic planning and guidance on all regulatory projects and solutions in the region to effect optimal outcome
- Coordinate, support & manages the acquisition of New Marketing Authorisations in the region according to established processes and corporate strategies
- Coordinate, support & manages the acquisition of Clinical Trials Application Approvals in the region according to established processes and corporate strategies
- Coordinate, support & manages the maintenance of Marketing Authorisations in the region according to established processes and corporate strategies
- Help promote and monitor the implementation and compliance with Corporate Policies, Procedures, Guidelines & Systems
- Development and maintenance of regulatory databases
- Provide training and coaching to local regulatory affairs staff in the region

Attributes:
- Proven excellent management & leadership skills.
- Strategic approach to achieving goals & problem solving.
- Strong team player
- Pro-active personality with positive attitude.
- Excellent interpersonal skills.

Qualifications:
- Medical, Pharmacy or Science graduate.

Skills & Experience:
- At least 5 years proven track record in regulatory affairs for Multinational Pharma Companies preferably in a regional capacity
- Computer literate
- Fluent (verbal & written) in English

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