Regulatory Specialist (Clinical Trial/ Submission/ CTA)

Location Singapore
Discipline Pharmaceutical
Job Reference BBBH110137_1653459553
Salary S$4000 - S$5000 per month
Consultant Email apple.lim@manpower.com.sg
EA License No. 02C3423


Regulatory Specialist (Clinical Trial/ Submission/ CTA)

12-Months Contract
Location: Pasir Panjang
Salary: Up to $5000 depending on experience
Completion Bonus

Our client, a MNC company in BioPharmaceutical Industry is currently looking for Regulatory Specialist

Primary Function:

  • Responsible for providing global regulatory expertise for Clinical Trials. They are the primary interface between global functions and affiliates to deliver clinical development regulatory strategies, operations and outcomes



Major Responsibilities:

  • Manage a portfolio of CTAs including preparation and distribution of documentation associated with new initial CTAs and all CTA maintenance activities such as substantial amendments, end of trial notifications etc.
  • Provide advice on submission strategy, country requirements, etc. as well as operational support for Regulatory submission preparation and processing of amendments.
  • Review of and input on documents related to clinical trial submissions managed by other stakeholders such as IB, Protocols.
  • Ensure approved company CTA processes are followed within agreed timelines.
  • Monitor key project milestones (actual vs. planned activities and timelines) and identify and communicate issues/changes to assigned stakeholders and management as agreed in company procedures.
  • Support inspection readiness activities when applicable
  • Review and maintain awareness of regulatory intelligence relating to clinical trials and advise stakeholders accordingly.
  • Ensure all relevant databases and activity trackers are populated within agreed timelines and compliance/reporting requirements met, and provide operational support for Regulatory and/or non-Regulatory systems that are critical for Regulatory submission and maintenance activities.
  • Provide technical support on document preparation e.g. Excel spreadsheets, Power Point presentations.
  • Undertake all necessary training in order to achieve compliance with internal/external processes
  • Provide operational support for the CTS Team as required.
  • Comply with the company's policies and procedures to meet statutory, quality and business requirements within the overall strategy and objectives of company.



Requirements:

  • Bachelor's degree in medicine, pharmacy, biology, chemistry, pharmacology, or related life sciences subject is required.
  • At least 2-years CTA experience, preferably in global clinical trial submissions to regulatory agencies.



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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