Asia Pacific Regulatory Affairs Director

1 day ago


Singapore A. MENARINI ASIA-PACIFIC HOLDINGS PTE. LTD. Full time
Job Description

A. MENARINI ASIA-PACIFIC HOLDINGS PTE. LTD. is seeking a highly skilled Regional Regulatory Affairs Executive to lead our team in Asia Pacific.

About the Role

The successful candidate will be responsible for managing the registration submissions and lifecycle of pharmaceutical products in APAC regions, including ASEAN, Greater China, Hong Kong & Macau, Taiwan, India, South Korea, Australia and New Zealand, as well as new frontier markets.

You will be the regional lead in change management and compliance, line extension projects, and regulatory viability assessments. Additionally, you will provide solutions to overcome regulatory hurdles, reduce inventory risk, and shorten dossier preparation time.

About You

To succeed in this role, you will have at least 1 year of regional regulatory affairs experience on pharmaceuticals with track records of lifecycle and/or new registrations. You must possess a degree in Pharmacy/Pharmaceutical Sciences and have attention to details.

As a collaborative team player, you will work at a fast pace in multidisciplinary matrix organisations and adapt to IT systems to facilitate work processes.

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
Requirements
  • 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 in multidisciplinary matrix organisations. Easily adapts to IT systems to help facilitate work processes
Salary

The estimated salary for this role is SGD $120,000 - $180,000 per annum, depending on experience and qualifications.



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