Senior / Executive - Regulatory Affairs *Pharma / Cosmetic*

Recruit Express Pte Ltd| Date Posted: 21-Sep-2020
EA Licence No: 99C4599|EA Personal Registration No: R1875289
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Job Nature:
Permanent, Contract
Position Level:
Experienced
Qualification:
Diploma, Bachelor's / Honours, Masters / PhD

Job Description

Job Scope:

  • Regional Lead in  new registration submissions of  pharmaceutical products in  APAC regions
  • 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 to overcome regulatory hurdle
  • 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
  • Manage relationships with various partners’ regulatory function stakeholders
  • Maintain relevant databases for registrations and status as required
  • Other ad-hoc duties requested time from time from superior/cross-functional colleagues

Requirements:

  • Candidate must possess at least a Bachelor's Degree in Biological Sciences / Pharmacy
  • Registration with Singapore Pharmacy Council
  • Minimum 2 - 4 years of regulatory affairs experience on pharmaceuticals

Interested candidates can write in to Ann at anngoh@ recruitexpress.com.sg

Ann Goh Xin Ting
R1875289
E.A License: 99C4599

Company Overview
Recruit Express Pte Ltd