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Senior Regulatory Affairs Manager (Oncology)

Senior Regulatory Affairs Manager (Oncology)

RandstadHong Kong
30 天前
职位描述

job details

about the company.

Our client, a world-class leading pharmaceutical manufacturing company, is currently looking for a Regulatory Affairs Manager (Oncology) to join their expanding team.

about the job.

  • Independently lead and manage regulatory submissions, including CTA and NDA filings and obtain timely approval ...
  • Maintain product registration certificates by timely submission and approval of variations and renewals
  • Prepare regulatory submissions which require interactions with departments outside of Regulatory Affairs for investigational and commercial products in line with ICH requirements based on Hong Kong / Macau regulations, regional requirements and scientific and company policies and procedures

skills & experiences required.

  • University graduate in Science or Pharmacy (preferably registered pharmacist in Hong Kong)
  • Minimum 5 years of relevant experience in Regulatory Affairs for Hong Kong and Macau (Candidates with more experience may consider as Senior Manager)
  • Must have Oncology experience
  • Interested individuals can click apply now and send through an updated resume in WORD format. For a more comprehensive list of current opportunities, please visit https : / / www.randstad.com / jobs / q-hong-kong / or contact Jessica Cheung at + 852 6285 6991 or email jessica.cheung@randstad.com.hk

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    about the company.

    Our client, a world-class leading pharmaceutical manufacturing company, is currently looking for a Regulatory Affairs Manager (Oncology) to join their expanding team.

    about the job.

  • Independently lead and manage regulatory submissions, including CTA and NDA filings and obtain timely approval
  • Maintain product registration certificates by timely submission and approval of variations and renewals
  • Prepare regulatory submissions which require interactions with departments outside of Regulatory Affairs for investigational and commercial products in line with ICH requirements based on Hong Kong / Macau regulations, regional requirements and scientific and company policies and procedures
  • skills & experiences required.

  • University graduate in Science or Pharmacy (preferably registered pharmacist in Hong Kong)
  • Minimum 5 years of relevant experience in Regulatory Affairs for Hong Kong and Macau (Candidates with more experience may consider as Senior Manager)
  • Must have Oncology experience
  • Interested individuals can click apply now and send through an updated resume in WORD format. For a more comprehensive list of current opportunities, please visit https : / / www.randstad.com / jobs / q-hong-kong / or contact Jessica Cheung at + 852 6285 6991 or email jessica.cheung@randstad.com.hk

    humanforward

    show more

    skills

    no additional skills required

    qualifications

    no additional qualifications required

    education

    Bachelor Degree

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    Senior Manager • Hong Kong