Regulatory Specialist (Clinical Trial/ Submission/ CTA)
Location: Pasir Panjang
Salary: Up to $5000 depending on experience
Our client, a MNC company in BioPharmaceutical Industry is currently looking for Regulatory Specialist
- 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
- 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.
- 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.firstname.lastname@example.org
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