Specific activities and responsibilities:

Must have expertise in Health Authority communications for Initial filings, LCM Activities and for variation submissions.

 

Must have experience and thorough knowledge of the process of submissions at HA without missing any detail or deadline.

 

Must be competent with the current changes and regulations from the HA and be able to provide required local regulatory intelligence related to initial filings, variation submission (major, minor, line extension etc.), artwork requirement.

 

Will be able to provide local support for clients submission filings specially in PH/MY/SG.

Required education:

Masters in life science discipline (preferable), Bachelors can be considered for rightful candidates

Required experience :

overall 7-8 years in Regulatory Affairs with At least 4-5 years of experience as Regulatory Affairs Specialist (or Senior specialist or RA Manager).

Required languages:

Fluency in Malay (reading and writing) would be preferable for Malaysian candidates

Required technical skills:

  • Regulatory Assessment for Quality and Safety changes (inc labelling updates and non CMC administrative changes)
  • Creation/update Country Label Deviation
  • Update and approval local artworks
  • Provision of local reg intel
  • Update local site licenses (GMP site renewals)
  • Local Regulatory SOP review and update
  • Health Authority Fee maintenance
  • Coordinate of Response to Questions
  • Preparation/update Product Information
  • Preparation /update local abbreviated PI (if applicable)
  • Preparation of Renewal Procedure eg local document identification and preparation
  • Preparation for Variations inc. RtQs, requesting/securing centrally provided documentation
  • Preparation for Annual Safety Updates/HA instructed safety updates
  • Regulatory support in relation to local requirements relating to cessation of marketing / sunset clause / withdrawal of Mas

Providing support during external and unannounced audits.

RAS APAC 327

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