HEAD, GLOBAL REGULATORY SCIENCE

Become a member of a visionary, audacious and award-winning team that is tackling healthcare inequities by building domestic biomanufacturing capacity in Africa.

At Bio Usawa (and our Rwandan subsidiary, Bio Usawa Biotechnology, Ltd.), we understand that our mission of bringing affordable and accessible biomedicines to patients in Low-Middle Income Countries (LMICs) cannot be realized without high-performance teams that are passionate and road-tested.

We are seeking talented individuals who have a desire to work collaboratively in a diverse, fast-paced environment in which understanding-yet questioning-conventional wisdom and implementing resourceful solutions are highly valued.

The Head of Global Regulatory Science, reporting to the Chief Regulatory Officer, will recommend, develop and implement regulatory plans that will enable BUI to build manufacturing, testing, and commercialization capabilities within an initial country, then regionally, in Africa. The individual will also be expected to recommend and develop collaborations with key partners in support of BUI’s ambitious timelines and plans for success.

• Develop and execute regulatory strategies for the company's product pipeline, ensuring alignment with business objectives and compliance with global regulations.
• Lead interactions and negotiations with regulatory agencies like the FDA and EMA, serving as the primary point of contact for regulatory matters.
• Oversee the preparation and submission of regulatory filings and other key documents, where appropriate.
• Provide strategic regulatory guidance to cross-functional teams, including R&D, manufacturing, quality assurance and commercialization.
• Stay current on evolving regulations and guidelines in the biotechnology industry, assessing their impact on the company's products and processes.
• Collaborate with the Executive Team to integrate regulatory considerations into overall business strategy and decision-making.
• Oversee post-approval regulatory activities, including lifecycle management, label updates, and compliance with post-marketing commitments.
• Ensure annual licenses, registrations, etc., are maintained.

• Chief Regulatory Officer

• Master’s or Doctoral degree in regulatory science or a related field.
• Minimum of 15 years of experience in regulatory affairs within the biopharmaceutical industry, OR 10+ years of service in senior level leadership roles in reputable regulatory agencies preferably with experience in monoclonal antibodies or biologics.
• Strong knowledge of regulatory requirements for monoclonal antibodies, including US-FDA, EMA, Central Drugs Standard Control Organization (India CDSCO), Canada Food Inspection Agency (CFIA), the UK- Medicines and Healthcare products Regulatory Agency and ICH guidelines.
• Experience with regulatory submissions, including INDs, CTAs, NDAs, BLAs etc.