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Regional RA Manager

Regulatory Affairs Manager, Regional

Job Description

  • Ensures appropriate oversight of potential post-approval regulatory activities, such as:
    1. Licence renewal applications
    2. Regulatory compliance reviews
    3. Change of ownership applications
    4. Variation applications
    5. Liaison with Regulatory Authorities
    6. Liaison with RA members in other Asian Affiliates and Licensees

Ensure the Project Team is provided with all required functional advice and support

Ensures that all project-related regulatory activities are conducted in a timely fashion and in compliance with overall regulatory strategy

Ensures that study documentation for regulatory purposes is prepared and submitted to Regulatory Authorities with the required content and format

Ensures that regulatory tasks managed within the scope of the Regulatory Affairs Manager role are managed in a manner in line with industry standards and Health Authority requirements

To gain and maintain knowledge of relevant internal SOPs and appropriate external guidance documents (e.g. China FDA, Korean FDA, ASEAN Guidelines, TGA Guidelines, etc.)

Ensures that Core Documents are prepared, reviewed and finalized according to applicable internal SOPs and external guidelines

To coordinate and participate in preparations for Regulatory Authority meetings including development of regulatory strategy, questions, background documentation etc. as required to ensure that the objectives of the meeting are achieved

Requirements

  • At least 5 years experience in Regulatory
  • Thorough understanding of the role of regulatory affairs
  • Knowledge of regulatory processes and requirements for NDA, maintenance of MA, variation in Asia and Oceania
  • (Knowledge of ICH-GCP guidelines and international regulatory requirements such as PIC/S)

If you meet the essential requirements for this position, please send your latest CV through the link provided , or call Vanessa Tan at +65 6871 4700 for further information.

Only shortlisted candidates will be notified via email

If you meet the essential requirements for this position, please send your latest CV through the link provided , or call Vanessa Tan at +65 6871 4700 for further information.

Registration no: R1873695

EA Licence no: 16S8216

Only shortlisted candidates will be notified via email.

Real, a trading division of SThree Pte Limited (Registration Number: 2007.20126E | SThree Pte Limited Licence Number 16S8216 | Real Licence Number 53132073A)

Award winner of:

International Recruitment Company of the Year by Recruitment International 2016

Life Sciences and Healthcare Recruitment Company of the Year by Recruitment International 2016

Best Overseas Operation by Global Recruiters 2017

Highly Commended for Best Large Recruitment Business 2017