Regional Regulatory Affairs Executive
5 hours ago
POSITION SUMMARY:
The Regional Regulatory Executive will be a key member of the team responsible for new registration submission and management of product life cycle of pharmaceutical products in Asia Pacific.
KEY RESPONSIBILITIES:
- Regional Lead in registration submissions of pharmaceutical products in APAC regions: ASEAN, Greater China, Hong Kong & Macau, Taiwan, India, South Korea, Australia and New Zealand and in new frontier markets e.g. Maldives, Sri Lanka, etc.
- Regional Lead in change management and compliance in APAC regions
- Regional Lead in line extension projects to serve commercial marketing needs
- Assess regulatory viability of bringing EU-approved products with local regulatory colleagues through understanding the quality, non-clinical and clinical data of the products to meet country- specific requirements
- Provide solutions to overcome regulatory hurdles, reduce inventory risk and also shorten dossier preparation time so to achieve speed to market
- Artwork approver of APAC common-pack and specific-pack artworks with knowledge of labelling requirements in individual countries
- Propose best recourse of action to meet compliance requirements for legacy non-compliance issues
- Able to represent regulatory affairs in cross-functional team and manages relationships with internal stakeholders: marketing, supply chain, medical affairs, quality assurance
- Develop relationships with various partners’ regulatory function stakeholders: product owners, manufacturers, distributors, external consultants
- Maintain relevant databases for registrations and status as required
- Other ad-hoc duties requested time from time from superior/cross-functional colleagues
KNOWLEDGE/ QUALIFICATIONS / SKILLS / EXPERIENCE:
- Candidate must possess at least a degree in Pharmacy/Pharmaceutical Sciences
- At least 1 year of regional regulatory affairs experience on pharmaceuticals with track records of lifecycle and/or new registrations
- Attention to details
- Ability to collaborate and work at a fast pace inmultidisciplinary matrix organisations. Easily adapts to IT systems to help facilitate work processes
Tell employers what skills you have
Change Management
Quality Assurance
Work Well Under Pressure
Regulatory Affairs
Critical Thinking
Oncology
Supply Chain
Medical Affairs
Attention to Details
Change Control
Regulatory Requirements
Databases
Africa
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