Clinical Trial Regulatory Submission Specialist

Recruit Express Pte Ltd| Date Posted: 26-May-2020
EA Licence No: 99C4599|EA Personal Registration No: R1875164
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Job Nature:
Permanent
Position Level:
Experienced
Qualification:
Bachelor's / Honours

Job Description

Description

  • The Regulatory Associate is 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 trials 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 DSUR, 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/administrative support for the Clinical Trials Regulatory Group
  • Participate in process improvement initiatives within CTRG and cross-functionally.
  • Support SOP reviews and updates when required.
  • Comply with the company’s policies and procedures to meet statutory, quality and business requirements within the overall strategy and objectives 
  • The candidate’s decisions can impact the deliverables of clinical R&D programs on key geographic areas, including program timelines and quality, affect the company’s image and credibility towards regulatory agencies and subsequently impact registration files, marketing authorizations and ultimately market access and sales.

Education

 

  • Bachelor's degree in medicine, pharmacy, biology, chemistry, pharmacology, or related life sciences subject is required.
  • At least 2-years Regulatory Affairs or Clinical Trials experience.
  • Experience working effectively across cultures and in a complex matrix environment
  • Good Information Technology skills, proven ability to utilise a variety of computer application packages, such as MS Word, Excel, PowerPoint, Adobe Acrobat and global databases.
  • Proactive verbal and written communication style at all levels.
  • Shows high level of initiative and ability to work independently
  • Has excellent communication/presentation skills, written and verbal; fluency in English.
  • Strong proven personal development and motivational skills.
  • Strong interpersonal, organisational and team working skills.

Interested candidates please submit your resume to [Click Here to Email Your Resume]

 

Jace Choo Oi Kei
Personnel EA License No.: R1875164
Recruit Express Pte Ltd (EA Licence No.: 99C4599)

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Recruit Express Pte Ltd