Senior Regulatory Specialist

Found in: Talent ZA C2 - 2 weeks ago


Bloemfontein, South Africa Parexel Full time

When our values align, there's no limit to what we can achieve.
 

REGISTER YOUR INTEREST for the upcoming Senior Regulatory & Submissions Specialist positions. As soon as the role becomes available, we will promptly send you an email invitation to apply officially.

Currently, the position is hybrid office-based.

Accountable for performance and compliance with assigned protocols in a country in compliance with ICH/GCP and country regulations, Client policies and procedures, quality standards, and adverse event reporting requirements internally and externally.

Experience required to be a fit for this role:

· Mandatory - experience in EC and RA submission (ideally, familiar with XML completion) – including initial submission and protocol amendments submission.

· Experience in Independently preparing submissions (CTC supports with

document collection) to both EC and RA.

· Experience in ICF preparation using templates.

· Skilled knowledge of the local regulatory environment, submissions, and approval processes, and understanding of how these impact study start-ups.

· Experience in IMP supplies management at the local level (vendors providing background meds, the standard of care, etc.)

· Experience in validation of translated documents.

We offer exceptional financial rewards, training, and development. Expect

exciting professional challenges but with a healthy work/life balance. We value your welfare just as highly as that of our patients.

#LI-TA1


  • Regulatory Affairs Associate

    Found in: beBee jobs ZA - 5 days ago


    Bloemfontein, Orange Free State, South Africa Parexel Full time

    We are looking for an experienced Regulatory Affairs Professional with working knowledge of Clinical Trail Applications (CTA) to join our team in South Africa This role can be office based (Bloemfontein) or home based anywhere in South Africa.As a Regulatory Affairs Associate you will ensure the timely performance of work within a project scope to the...

  • Regulatory Affairs Associate

    Found in: beBee S ZA - 6 days ago


    Bloemfontein, South Africa Parexel Full time

    We are looking for an experienced Regulatory Affairs Professional with working knowledge of Clinical Trail Applications (CTA) to join our team in South Africa! This role can be office based (Bloemfontein) or home based anywhere in South Africa.As a Regulatory Affairs Associate you will ensure the timely performance of work within a project scope to the...

  • Regulatory Affairs Associate

    Found in: Talent ZA C2 - 6 days ago


    Bloemfontein, South Africa Parexel Full time

    When our values align, there's no limit to what we can achieve.   We are looking for an experienced Regulatory Affairs Professional with working knowledge of Clinical Trail Applications (CTA) to join our team in South Africa! This role can be office based (Bloemfontein) or home based anywhere in South Africa. As a Regulatory Affairs Associate you...

  • Contracts Specialist

    Found in: beBee S ZA - 3 weeks ago


    Bloemfontein, South Africa Parexel Full time

    We are now looking for a Contracts Specialist to be based in South Africa (the role can be based in the office or home based anywhere in SA). In this role, you will amend, negotiate and finalise project budgets together with creating draft contractual documents.  You will have the opportunity to work closely with colleagues across various departments...

  • Senior Quality Specialist

    Found in: beBee S ZA - 4 weeks ago


    Bloemfontein, South Africa Parexel Full time

    We are currently looking for an experienced Quality Specialists to be based in South Africa.Your time hereAt Parexel, Quality Specialists act as a Quality partner for GDO Biostatistics and Statistical Programming, focusing on first-time quality, robust risk and issue management and maintaining an inspection-ready state. Provide quality expertise through the...

  • Senior Quality Specialist

    Found in: beBee S ZA - 2 weeks ago


    Bloemfontein, South Africa Parexel Full time

    We are currently looking for an experienced Quality Specialists to be based in South Africa.Your time hereAt Parexel, Quality Specialists act as a Quality partner for GDO Biostatistics and Statistical Programming, focusing on first-time quality, robust risk and issue management and maintaining an inspection-ready state. Provide quality expertise through the...

  • Senior Medical Writer

    Found in: Talent ZA C2 - 7 days ago


    Bloemfontein, South Africa Parexel Full time

    When our values align, there's no limit to what we can achieve.   Parexel is in the business of improving the world’s health. We do this by providing a suite of biopharmaceutical services that help clients across the globe transform scientific discoveries into new treatments. From clinical trials to regulatory, consulting, and market access, our...

  • Public Law Professor/Associate Professor/Senior Lecturer

    Found in: Talent ZA C2 - 2 weeks ago


    Bloemfontein, South Africa UFS, Bloemfontein Full time

    Please ensure that all relevant documentation is attached to your application.  • A detailed curriculum vitae and cover letter.  • Copies of qualifications (please provide the SAQA accreditation in the case of foreign qualifications). • Copies of all academic records (applicable where inherently required). • A copy of your identity document (ID...

  • Senior Client Manager

    Found in: Talent ZA C2 - 11 hours ago


    Bloemfontein, South Africa Aon Full time

    Senior Client Manager - Bloemfontein Are you a commercial insurance specialist based in Bloemfontein? Passionate about clients? Read on! Aon South Africa is recruiting a Senior Client Manager in our Commercial department based, on a hybrid basis, from our offices in Bloemfontein. The role of the senior client manager is to ensure that client...

  • Senior Data Team Lead

    Found in: Talent ZA C2 - 2 weeks ago


    Bloemfontein, South Africa IQVIA Full time

    Job Overview Independently manage end-to-end delivery of data management services for single/multi-service projects, ensuring quality deliverables on time and within budget, to customer satisfaction. Provide comprehensive data management expertise to Clinical Data Management (CDM) team to provide high quality data management products that meet customer...


  • Bloemfontein, South Africa UFS, Bloemfontein Full time

    Please ensure that all relevant documentation is attached to your application.  • A detailed curriculum vitae and cover letter.  • Copies of qualifications (please provide the SAQA accreditation in the case of foreign qualifications). • Copies of all academic records (applicable where inherently required). • A copy of your identity document (ID...

  • Senior Data Team Lead, home-based in South Africa

    Found in: Talent ZA C2 - 2 weeks ago


    Bloemfontein, South Africa IQVIA Full time

    RESPONSIBILITIES Serve as primary point of contact for customer on data management deliverables Manage multiple large studies or program of studies (possibly global) Provide leadership and senior support to DTLs on multiple large global programs of global studies Provide project management expertise working with customer data managers, key decision...

  • Senior Property Financial Consultant

    Found in: Talent ZA C2 - 2 weeks ago


    Bloemfontein, South Africa Tower Group Full time

    Job DescriptionKey Responsibilities:To actively prospect potential home loan clients, through lead providers (agents and originators) and through personal marketing and people engagement opportunities, then by using the appropriate needs analysis based selling techniques, either switches them from other financial institutions or to offer them a new home...

  • Master Data Officer

    Found in: Talent ZA C2 - 2 weeks ago


    Bloemfontein, South Africa Shoprite Full time

    Purpose of the Job The role of the Master Data Officer is to be the first line support to the divisional offices, where the role is responsible to support with SAP data administrative services and ensuring that the butcheries can accurately process and transact information. The role will support the divisional offices with drawing of transacting...