Regulatory Affairs Specialist (Medical/ Therapeutic)

Location Singapore
Discipline Pharmaceutical
Job Reference BBBH111454_1650696575
Salary S$4500 - S$6500 per month
Consultant Email
EA License No. 02C3423

Regulatory Affairs Specialist (Medical/ Therapeutic Products)

12-Months Contract
Location: Pasir Panjang
Salary: Up to $6500 depending on experience
Completion Bonus

Our client, a MNC company in BioPharmaceutical Industry is currently looking for Regulatory Specialist to join the team .

Primary Function:

  • Responsible for management of integration projects.
  • Plan and prepare regulatory submissions of therapeutic products and medical devices.
  • Support lifecycle management activities and ensure regulatory compliance is maintained.

Integration Projects:

  • Manage integration projects for Singapore and Philippines.
  • Review all current approved labels to ensure the content is in accordance with local regulatory requirements, local regulatory approved documents and reference documents.
  • Identify label deviations and collaborate with cross functional stakeholders to determine the remediation plan.
  • Plan for notification and submission to the Regulatory Authority, where applicable.
  • Manage marketing authorization transfer activities for therapeutic products and medical devices.
  • Monitor the progress and provide updates on project status during meetings.
  • Manage labeling changes, artwork development and artwork approval of packaging material components.
  • Update and maintain regulatory databases.


  • Keep up to date for law & regulations knowledge related to integration projects.
  • Monitor and disseminate information on changes related to the Regulatory Authority Department: law & regulations affecting registration, manufacture, distribution,sale & marketing of AbbVie products and related to integration projects.
  • Facilitate communication between cross functional stakeholders, Area Regulatory lead, local
  • regulatory authority and local distributor.

Product maintenance:

  • Review, analyze and co-ordinate data for variations submission to marketed products according to priorities and responses to deficiency letters.
  • Monitor progress of variations approval process within Regulatory Authority.
  • Liaise and negotiate with the relevant authorities to facilitate and secure expeditious regulatory approvals.
  • Manage labeling changes, artwork development and artwork approval of packaging material components
  • Update and maintain regulatory databases


  • Bachelor's Degree in Pharmacy, Biological Sciences, Life Sciences or Pharmaceutical related studies
  • Minimum 2 years experiences in regulatory function in a pharmaceutical and medical device
  • Understands business needs and impact of regulatory issues

If you possess above relevant skillsets, please send in your updated CV in word format to

Lim Pey Chyi
Recruitment Consultant (R2090579)
Manpower Staffing Services (S) Pte Ltd
EA Licence: 02C3423

Apple, Pey Chyi Lim EA License No.: 02C3423 Personnel Registration No.: R2090579

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