Regional Regulatory Affairs Executive
Full-time
Senior Executive
1 week ago
POSITION SUMMARY:
The Regional Regulatory Executive will be a key member of the team responsible for new registration submission and management of pro..
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
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