Regulatory Operation Specialist - Pharma MNC

Recruit Express Pte Ltd| Date Posted: 23-Feb-2021
EA Licence No: 99C4599|EA Personal Registration No: R1763413
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Job Nature:
Permanent, Contract
Position Level:
Diploma, Bachelor's / Honours

Job Description

Job descriptions:

  • Strategically project manage the collation of submission documents, submissions, responses to regulatory authority questions and approvals for new products and product variations across Asia
  • Support the planning and execution of submission strategies for all regulatory submissions across Asia, to maximise the likelihood of regulatory approval and speed to market
  • Serve as the key internal regulatory liaison for asia RA teams and distributors throughout Asia
  • Support the development and implementation of regulatory procedures and processes to promote harmonisation and standardisation, where practicable, and ensure operational efficiency and effectiveness across Asia
  • Adopts and assures alignment of company's regulatory information management system with other organizational systems
  • Support regulatory due diligence, and the collation and dissemination of technical information including dossiers, product lists, formulations and artworks
  • Assist in interpretation and anticipation of company impact of new and changing regulations/ guidances and health authority expectations, and communicate the impact to key stakeholders across the business

Job Requirements: 

  • Min. Diploma/ Degree in Pharmacy/ Medical/ Science
  • Min. 2-3 years’ experience in pharmaceutical industry
  • Experience in working in regional regulatory affairs in a multinational pharmaceutical company would be an advantage 

For interested applicants, please send your updated resume to: [Click Here to Email Your Resume]

All candidates’ informations will be treated with the strictest confidence

Alex Goh Hock Leong (Alvin)

Recruit Express Pte Ltd
EA No. 99C4599

Company Overview
Recruit Express Pte Ltd