Regulatory Specialist

2 weeks ago

Singapore Emprego SG Full time

**Salary**: up to $5500

**Duration**: 1 year contractWorking Days & Hours: Mon-Fri Office HoursLocation: Tuas
- 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
- This position reports to the Manager, CTS

**Job Requirements**: Degree in medicine, pharmacy, biology, chemistry, pharmacology, or related life sciences

4 Year Degree

  • Regulatory Operations Specialist

    1 week ago

    Singapore beBeeregulatory Full time $90,000 - $120,000

    Regulatory Operations SpecialistWe are seeking a highly skilled Regulatory Operations Specialist to manage global regulatory submissions and dossier publishing tasks. The successful candidate will be responsible for daily activities and deliverables in this role.Key Responsibilities:

  • Regulatory Affairs Specialist

    17 hours ago

    Singapore ProductLife Group Full time

    We are looking for a highly motivated and detail-oriented Regulatory Affairs Specialist to join our consulting company. As a Regulatory Affairs Specialist, you will play a crucial role in ensuring compliance with regulatory requirements for the development, approval, and marketing of pharmaceutical products on a global scale.Your responsibilities will...

  • Regulatory Affairs Specialist

    13 hours ago

    Singapore ProductLife Group Full time

    We are looking for a highly motivated and detail-oriented Regulatory Affairs Specialist to join our consulting company. As a Regulatory Affairs Specialist, you will play a crucial role in ensuring compliance with regulatory requirements for the development, approval, and marketing of pharmaceutical products on a global scale.Your responsibilities will...

  • Regulatory Compliance Specialist

    11 hours ago

    Singapore beBeeCompliance Full time $150,000 - $200,000

    Regulatory Compliance SpecialistWe are seeking an experienced Regulatory Compliance Specialist to join our team. This role will be responsible for ensuring adherence to laws and regulations, advising businesses, updating policies and procedures, managing audits and inquiries, and conducting compliance reviews and testings.Key Responsibilities:Advise...

  • Regulatory Compliance Specialist

    5 days ago

    Singapore beBeeCompliance Full time

    Regulatory Compliance SpecialistWe are seeking a highly skilled Regulatory Compliance Specialist to join our team. The ideal candidate will have excellent communication and organizational skills, with the ability to analyze complex regulatory requirements and implement effective solutions.Job Responsibilities:Communicate new and updated regulatory...

  • Regulatory Compliance Specialist

    2 days ago

    Singapore beBeeRegulatory Full time $120,000 - $160,000

    Job Title: Regulatory Compliance SpecialistA key role responsible for conducting regular reviews and investigations to ensure adherence to regulatory requirements.

  • Regulatory Compliance Specialist

    1 day ago

    Singapore beBeeCompliance Full time $80,000 - $120,000

    Regulatory Compliance SpecialistWe are seeking a highly skilled Regulatory Compliance Specialist to join our team in Singapore. This expansion role is designed to strengthen our compliance function and ensure adherence to regulatory requirements, while supporting business growth across various financial products.Key Responsibilities:Provide expert compliance...

  • Regulatory Affairs Specialist

    4 days ago

    Singapore Johnson & Johnson Full time

    The Regulatory Affairs Specialist (MD) is a member of the local Regulatory Affairs department, responsible for activities to support and actively contributing to the regulatory compliance of medical devices products under their responsibility. - The Regulatory Affairs Specialist (MD) will be a member of the local regulatory affairs department within Johnson...

  • Regulatory Compliance Specialist

    5 hours ago

    Singapore beBeeRegulatory Full time $2,000 - $4,800

    Job Title: Regulatory Compliance Specialist">We are seeking a skilled and detail-oriented individual to join our team as a Regulatory Compliance Specialist. This role will be responsible for ensuring that our products meet all relevant regulatory requirements, from initial product design through to market launch.">Main Job Scope:Manage the development and...

  • Regulatory Affairs Specialist

    3 days ago

    Singapore Johnson & Johnson Full time

    Johnson & Johnson is currently seeking a Regulatory Affairs Specialist to join our Regulatory Affairs team located in Singapore. : The Regulatory Affairs Specialist is a member of the Local Operating Company (LOC) Regulatory Affairs team and is responsible for preparation of life cycle management submissions to the Health Authority. Globally dispatched life...