Regulatory Affairs Professional with Clinical Trial Expertise

2 days ago


Bloemfontein, Orange Free State, South Africa Parexel Full time

Parexel: A Leading Provider of Biopharmaceutical Solutions

We are a premier biopharmaceutical solutions organization, offering a wide range of services to support the development and delivery of innovative therapies.

About the Role:

As a Senior Regulatory Affairs Associate at Parexel, you will play a critical role in ensuring the timely performance of work within a project scope to meet the quality expectations of internal stakeholders and clients. Your specialist knowledge of clinical trial submissions in Sub-Saharan countries will be invaluable in this position.

Key Responsibilities:

  • Local Submissions Management: As Local Regulatory Contact (LRC), you will manage local submissions, ensuring compliance with regulatory requirements.
  • Regulatory Lead Coordination: You will coordinate regulatory submissions in all participating countries as Regulatory Lead.
  • Clinical Trial Regulation: Your expertise will be essential in regulatory submission of Clinical Trials in the region.
  • Project Collaboration: Participate in Regulatory Operations meetings, project team meetings, and maintain relationships with other departments, clients, and regulatory agencies as necessary.
  • Leadership and Mentorship: You may lead or be involved in local, regional, and/or global projects, guiding and mentoring junior team members.

Requirements:

  • Education: University degree in a science discipline.
  • Clinical Trial Experience: Background in clinical trial management and 3-5 years of Regulatory Affairs experience working with Clinical Trail Applications in South Africa.
  • Regional Expertise: Experience with clinical trial submissions in other Southern African Countries.
  • Technical Skills: IT knowledge, including Veeva Regulatory and Clinical Vaults, Excel, VBA, and Power BI.
  • Soft Skills: Customer-oriented, autonomous, fluency in English is a must along with the local language.

What We Offer:

We offer a competitive salary ranging from R550,000 - R700,000 per annum, depending on experience, as well as opportunities for growth and professional development in a dynamic and supportive environment.



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