regulatory affairs senior executive/specialist in Singapore

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job details

posted
location
singapore
specialism
life science
job type
permanent
reference number
90M0342381_1522998194
contact
jin quan jonathan soh, randstad
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job description

Accountability 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.

Responsibilities include but not limited to:

  • Regional Lead in new 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 eg. 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 legitimate solutions (redressing, commitment letters, bridging reports, amending study protocol etc) 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
  • Proposes best recourse of action to meet compliance requirements for legacy non-compliance issues
  • Sits independently in cross-functional team and manages relationships with internal stakeholders: marketing, supply chain, medical affairs, quality assurance
  • Manages relationships with various partners’ regulatory function stakeholders: product owners, manufacturers, distributors, external consultants
  • Other ad-hoc duties requested time from time from superior/cross-functional colleagues

Required requisites:

  • Candidate must possess at least a Bachelor's Degree in Biological Sciences
  • At least 2 years of regulatory affairs experience on pharmaceuticals
  • Proficient in both oral and written English. Knowledge of Mandarin is a plus to liaise with Chinese-speaking counterparts in China & Taiwan
  • Attention to details
  • Ability to influence and collaborate with people at all levels effectively