regulatory affairs specialist (contract) in Singapore

posted
contact
jin quan jonathan soh, randstad
job type
contract
apply now

job details

posted
location
singapore
specialism
life science
job type
contract
working hours
Full-Time
reference number
91M0129874_1548642403
contact
jin quan jonathan soh, randstad
apply now

job description

about the company
An established European pharmaceutical company with over 100 years of history


about the job

Regulatory Affairs (RA)

  • Prepares and submits regulatory applications and keeps product registration files updated
  • Keeps track of all registration activities including Marketing Authorization Applications (MAAs), Marketing Authorization Renewals (MARs) and Marketing Authorization Variations (MAVs)
  • Works closely with Corporate Regulatory Affairs (cRA), Sourcing Partner and local Regulatory Partners on registration matters
  • Keeps abreast of updated regulations in the region via close communication with local Regulatory Partners
  • Supports local Regulatory Partners to negotiate and liaise with local Regulatory Authorities to expedite early regulatory approvals while developing and pursuing excellent working relationships
  • Manages labeling text and packaging components to ensure compliance with local regulatory guidelines and corporate prescribing information requirements
  • Ensures proper documentation of all registration applications and communications with Regulatory Authorities, while adhering to Regulatory Affairs working procedures and SOPs

SIMBA (Product Quality Complaints)

  • User of SIMBA Module for Product Quality Complaints
  • Any other adhoc duties as assigned by immediate manager


about the manager/team
This role reports in to the Head of South Asia regulatory affairs based in Singapore

skills and experience required

  • Degree in Science or Pharmacy
  • 1-2 years of regulatory experience in a pharmaceutical environment
  • Familiar with the regulatory framework in Singapore.
  • Working knowledge of regulatory procedures and submissions in other Asian markets would be an advantage
  • Able to work independently and also be a team player
  • Self motivated to accomplish performance objectives



To apply online please use the 'apply' function, alternatively you may email Jonathan at jonathan.soh@ randstad.com.sg.
(EA: 94C3609/R1656945)



skills

no additional skills required

qualification

no additional qualifications required

educational requirements

Bachelor Degree