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Keywords / Skills : RA Manager

6 - 11 years
Posted: 2018-12-15

Pharmaceutical/ Biotechnology
Other Pharma
Posted On
15th Dec 2018
Job Ref code
Job Description
  • Fast growing IVD company with increasing clinical foothold in APAC regions
  • Travelling opportunities across APAC and liaising with various regulatory authorities
  • Amazing work culture and benefits

A global IVD company is inviting meticulous, organized and highly motivated personal to join their regulatory affairs team as a RA manager. You will be reporting to the senior manager of regulatory affairs and assisting her regulatory submissions for new products, variations or renewals both locally and across APAC. You will be interacting frequently with internal and external stakeholders, providing specific regulatory guidance and ensure that regulatory plans are in-sync with business requirements.

  • Submissions and following up of product registrations to various regulatory bodies in a timely manner. Exercise due diligence in reviewing technical documents to fulfill different regulatory bodies’ requirements.
  • Liaise with both internal and external stakeholders to ensure regulatory compliance and provide regulatory advice whenever necessary
  • Mentoring and training of internal team of regulatory specialists, APAC affiliates and business units/partners
  • Assisting the RA manager in the development and implementation of regulatory strategies for various projects to ensure operational excellence and support business requirements
  • Monitoring and maintaining of reports and databases

  • Bachelor’s degree or equivalent in Medical Science or related scientific discipline
  • Minimum 6 years of regulatory experience in IVD or medical devices industry is preferred
  • Good communications skills in English (both oral and written) to facilitate accurate information flow between departments
  • Ability to travel (up to 20%) as the role covers across APAC regions

Please send your resume in WORD format by clicking the apply button below or contact Kareen Wong on +65 6701 1518 for a confidential discussion. Please note that only short-listed candidates will be contacted. CEI Reg. Number R1878552 (Wong Yin Ling, Kareen).
Key Skill(s)

About Company

EA Registration No. 12C5526

Founded in 1950, and established in Asia in 2004, VOLT is a NYSE listed Fortune 1000 provider of talent (recruitment), technology and consulting services with 4,200 full time employees, some 30,200 contractors and 192 offices across Europe, North and South America and Asia.

Volt's workforce solutions include executive search, contract and temporary staffing, managed services programs, vendor management systems and recruitment process outsourcing. Volt combines consultative focus, Six Sigma practices and efficient e-procurement technologies to deliver the talent and processes that help our customers succeed.
We connect companies with industry-leading specialists. Our proven search process cultivates a superior network of active and passive professionals, enabling us to provide best-fit experts in a broad range of business disciplines.

Our areas of expertise include Accountancy & Finance, Engineering, Human Resources, Information Technology & Telecommunications, Life Sciences, Procurement & Supply Chain, Property, and Sales & Marketing.
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