Regulatory and Start-up Manager at PRA Health Sciences

As a Regulatory and Start-up Manager you will be dedicated to one of our global pharmaceutical clients; a company that is advancing the development of new medicines, biologic therapies and vaccines for many of the world’s most challenging diseases including cancer, cardio-metabolic diseases, Alzheimer’s and infectious diseases. Be ready to work in a solid partnership and an environment driven by innovation and continuous improvement.

The Regulatory and Start up Manager is accountable for execution and oversight of local operational clinical trial activities in a country for assigned protocols in compliance with ICH/GCP and country regulations, policies and procedures, quality standards and adverse event reporting requirements internally and externally.

Responsibilities:

• Ownership of country and site budgets
• Development, negotiation and completion of Clinical Trial Research Agreements
• Responsible for execution and oversight of clinical trial country submissions and approvals for assigned protocols
• Responsible for managing country deliverables, timelines and results for assigned protocols to meet country commitments
• Responsible for quality and compliance in assigned protocols in the country
• Oversight and coordination of local processes
• Responsible for clinical and ancillary supplies management, importing and exporting requirements, supplies destruction, local electronic/hard copy filing, archiving and retention requirements, and insurance process

You are:

Passionate, innovative and committed.

Here at PRA we want our employees to succeed and ensure that they are set up for this success through constant training, development and support. To enable success in this position you will have:

• A minimum of a Bachelor’s degree in Life Sciences
• 5 years prior experience of working in investigator site management, including conducting monitoring visits, from either a pharmaceutical company or a CRO environment
• Solid experience in start up activities
• A working knowledge of ICH-GCP guidelines and local and international regulatory requirements is essentia
• Fluent Afrikaans and English language is a must