ADN Singapore – Regulatory Affairs Consultant

Regulatory Affairs Consultant

Permanent

$1,000 monthly

As part of our development, we strengthen our teams and we recruit, in the department Research & Development / Pharmacovigilance / Regulatory Affairs, a consultant scientific background Regulatory Affairs / Quality Assurance / Pharmacovigilance - H / F based in Singapore.
ADN is a French company specializing in services for Pharma and Life Sciences Industries.
Our business-oriented structure is constantly expanding both in terms of number of emloyees than skill.


In the field of regulatory affairs, you will have (based on your profile) missions in a highly regulated environment:

• Prepare variation for submission and follow up on input request
 a. Core Data sheet Update – Package Insert Update
 b. Quality module update
• Relationship with Health Sciences Authority and sites : Artwork co-ordination between HSA and Site for approval and approve artwork file
• Quality Assurance : Prepare SOP and creating forms
• Clear post approval commitment
• Update database information


Ideal Background

• Education (minimum):
 A degree in pharmacy, health discipline or life sciences
• Languages:
 Fluent in both written and spoken English
• Experience/Professional requirement:
 Minimum 2 years in Regulatory Affairs
 Quality Assurance experience including SOP management
 knowledge in national and international regulations (Regulatory guidelines like HSA guidelines)
 Excellent organisational and interpersonal skills
 Excellent communications and negotiation skills
 Computer knowledge
• Other requirement:
 Able to station in Singapore and travel to South East Asia.