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CMC Consultant

  • Job type Contract
  • Salary competitive
  • Location Singapore, Singapore
  • Sector Regulatory Affairs

Regulatory Affairs CMC Consultant

Real Staffing is currently working with a Global Pharma MNC and they are currently looking for a Regulatory Affairs CMC Consultant to join their project in Singapore. This position is an exciting opportunity that allows you to work closely with the Regional Regulatory Affairs team in a fast pace environment.

Location: Singapore

Duration: 3-6 months

Budget: Competitive Market Rate

Key responsibilities:

  • Lead CMC compliance gap assessment for local products in SEA.
  • Support the remediation of product specific regulatory documentation in alignment with registered information, internal product specifications, current global GMP regulations and requirements.
  • Activities include CMC internal documentation submission review, gap assessment, risk assessment, internal document remediation, translation and uploading of documentation into repositories/ databases.
  • Review, including and not limited to, evaluation of analytical procedures and methodology, manufacturing processes and controls, container closure and stability.

Qualifications:

  • Bachelor's Degree in Pharmacy or equivalent
  • At least 9 years of experience in regulatory affairs in pharmaceutical industry
  • Good understating of regulatory practices (Submission and variation)
  • Technically competent to understand CMC submissions, interpret and communicate requirements

If you are interested in the above described position, appreciate if you can apply through the link provided or contact Angelica Desiongco at +65 68009560 for a confidential discussion.

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