Senior Officer Regulatory

Job Posting Organization:
The organization is the largest nonprofit dedicated to combating poverty, disease, and inequity globally. Founded on the principle that everyone deserves the opportunity to lead healthy and productive lives, the organization emphasizes diversity among its employees to reflect the populations it serves. It offers a comprehensive benefits package, including medical, dental, and vision coverage with no premiums, generous paid time off, paid family leave, retirement contributions, and opportunities for employee engagement in various communities. The organization is committed to fostering a supportive work environment that promotes personal and professional growth.

Job Overview:
As a Senior Officer Regulatory, you will play a crucial role in managing and developing a portfolio of grants aimed at optimizing regulatory systems for medical products in low-income countries, particularly in sub-Saharan Africa. Reporting to the director" style="border-bottom: 1px dotted #007bff !important;">Deputy Director of Regulatory, Integrated Development, you will work remotely from the United Kingdom or Belgium. Your responsibilities will include supporting the establishment of an agile and impactful African Medicines Agency (AMA) and collaborating with the World Health Organization (WHO) to strengthen regulatory systems. This position requires a creative and analytical mindset, as you will be expected to identify problems and develop innovative solutions in the regulatory affairs domain, particularly focusing on European regulatory affairs and international regulatory systems.

Duties and Responsibilities:
Your primary duties will include managing a complex network of implementing partners and grantees, conducting site visits, providing technical guidance, and convening stakeholder meetings. You will review grant proposals, provide funding recommendations, and partner with grantees to define project outcomes and milestones. Additionally, you will ensure robust monitoring and evaluation systems are in place to assess performance against established objectives. Collaborating with internal teams, you will manage documentation, budget information, and grant reporting. You will also represent the foundation to external constituencies, deliver presentations, and produce informative materials for the Global Health team and foundation leadership. Travel is expected to be around 35%, primarily within Europe, Africa, and the United States.

Required Qualifications:
Candidates must possess an advanced degree (MD, PhD, or LLM/JD) with significant expertise in regulatory affairs or experience in a national/regional medical products regulatory agency. Deep knowledge of the European regulatory system and experience with the EMA or WHO is preferred. Strong problem-solving skills, project leadership, and excellent communication abilities are essential. The role requires the ability to work collaboratively in a team-oriented environment and manage complex projects effectively. Self-motivation and strong organizational skills are necessary to navigate the demands of the position.

Educational Background:
An advanced degree is required, with a preference for candidates holding an MD, PhD, or LLM/JD. Significant expertise in regulatory affairs or experience within a regulatory agency is highly valued. Educational qualifications should reflect a strong foundation in the principles of regulatory science and public health.

Experience:
Candidates should have demonstrated experience in regulatory affairs, particularly within the context of vaccines, biologics, drugs, and diagnostics. Experience working with the EMA and WHO is strongly preferred, along with a proven track record of developing and implementing regulatory projects in Europe and Africa. The ideal candidate will have experience in pharmaceutical regulatory affairs, from research and clinical development to post-authorization and life-cycle management.

Languages:
Fluency in English is mandatory, with conversational competency in French preferred. The ability to communicate complex regulatory and scientific concepts to a diverse audience is essential for this role.

Additional Notes:
This position is remote, allowing for flexibility in work location. The role is expected to involve travel approximately 35% of the time, primarily to Europe, Africa, and the United States. The organization emphasizes a commitment to diversity, equity, and inclusion in its hiring practices and workplace culture. All employment offers are contingent upon successful completion of a background check.