Senior Regulatory Affairs Specialist - Pharmaceuticals

Senior Regulatory Affairs Specialist - Pharmaceuticals

Persolkelly
Not Specified
Not Specified

Job Description



Key Responsibilities:
  • Prepare plan and set up process for filing new medicine applications and maintenance of registration of existing products with regulatory authorities in timeline required
  • Notify regulatory authorities of changes to medicines
  • Maintain the process for update label based on requirement of global for products responsible the monitoring of packaging and labelling
  • Assist in the monitoring of PV system if any
  • Obtain regulatory approval within optimum timelines and subsequently ensure new products are made accessible in the fastest time possible
  • Ensure immediate regulatory authority notification in relation to medicine changes
  • Help to maintain high quality and accurate packaging and labelling of the company's products
  • Develop and implement time and cost saving initiatives for this role
  • Develop and implement services to assist in delivering better value to customers
  • Specific measures as per personal performance grid
  • Good collaboration with other function team for supporting business

Key Requirements:
  • University graduate major in medicine/pharmacy
  • Prior experience in the pharmaceutical industry at least five years
  • Familiar with policies and procedures of Ministry of Health
  • Good working knowledge of applicable laws and regulations
  • Relevant knowledge of the health industry
  • Relevant knowledge of products and options
  • Competent in English language

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About Persolkelly

PERSOLKELLY is a joint venture established in 2016 between PERSOL HOLDINGS (previously Temp Holdings) and Kelly Services to cater to the rising workforce employment needs of the emerging Asia Pacific market. We are one of the largest workforce solutions providers in the region, spanning over 45 offices across 13 markets including Australia, China, Hong Kong, India, Indonesia, Malaysia, New Zealand, Philippines, Singapore, South Korea, Taiwan, Thailand and Vietnam.

Job Source : www.persolkelly.com.vn

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