Total 1 job vacancies by A. Menarini Asia-pacific Holdings Pte. Ltd.

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