Senior Executive, Regulatory Affairs | Tagore Lane

Location Singapore
Discipline Healthcare & Medical
Job Reference BBBH98586_1624424865
Salary S$3000 - S$4000 per month
Consultant Name Wee Ben Ann, Andy
Consultant Email
Consultant Contact No. 62328831
EA License No. 02C3423
Consultant Registration No. R1552080

Job Description

  • To oversee the regulatory approval and product registration for medical devices and cosmetics for local and regional offices with the support of local counterparts.

  • Liaise with the Singapore regulatory authority as well as overseas partners pertaining to regulatory affairs, including product registrations, variations to existing products and renewals.
  • Advise the local business divisions on regulatory and guideline requirements pertaining to their respective products.
  • Provide new product registration and license renewal progress updates on regular basis.
  • Provide guidance and direction to relevant parties on local regulatory requirements for product label change, manufacturing change, facility change, product line extension, shelf life and changes to technical specification of devices.
  • Maintain and update the business agreements with overseas partners.
  • Support and maintain compliance to the quality standards and certifications of the local office.

Job Requirements

  • Degree in Life Sciences or related fields.
  • Minimum of 1-2 years of relevant working experience in regulatory work.
  • Prior experience within the Medical Devices/Cosmetics/Pharmaceutical industries will be highly advantageous.
  • Possess excellent interpersonal and communication skills.

Andy, Wee Ben Ann License No. 02C3423 Personnel Registration No. R1552080

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