Senior Pharma Regulatory Affair Specialist **PERM**

Recruit Express Pte Ltd| Date Posted: 14-Sep-2020
EA Licence No: 99C4599|EA Personal Registration No: R1875164
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Job Nature:
Permanent
Position Level:
Experienced
Qualification:
Bachelor's / Honours

Job Description

KEY RESPONSIBILITIES:

  • 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 or justification letters, review and amend 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
  • Propose best recourse of action to meet compliance requirements for legacy non-compliance issues
  • Sit independently in cross-functional team and manages relationships with internal stakeholders: marketing, supply chain, medical affairs, quality assurance
  • Manage 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 Bachelor's Degree in Science Related Course (degree in Pharmacy will be advantageous)
  • At least 4 years of regulatory affairs experience on pharmaceuticals
  • Proficient in both oral and written English. Knowledge of Mandarin is a plus.
  • Attention to details.
  • Ability to influence and collaborate with people at all levels effectively.
  • Computer literate

Interested candidates please submit your resume to [Click Here to Email Your Resume]

Jace Choo Oi Kei
Personnel EA License No.: R1875164
Recruit Express Pte Ltd (EA Licence No.: 99C4599)

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