Regulatory Affairs Specialist (Medical/ Therapeutic)

Location Singapore
Discipline Pharmaceutical
Job Reference BBBH111454_1650696575
Salary S$4500 - S$6500 per month
Consultant Email apple.lim@manpower.com.sg
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.



Responsibilities:
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.



Regulatory:

  • 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



Requirements:

  • 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 Apple.lim@manpower.com.sg

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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