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While FDA experience is highly valued in the private industry, transitioning from the agency to private-sector employment requires new skills and a shift in mindset. This article provides resources for regulatory professionals with FDA experience seeking careers in the private sector. The article explores common career pathways in the medical device space, addresses key differences between the FDA and industry roles, and provides strategies for leveraging FDA experience outside the agency. The insights are based on the authors' experiences after departing from the FDA. The article is divided into two sections – the first outlining career pathways and the second offering advice on job hunting.

This article examines how various stakeholders, including academic institutions, regulatory-focused professional organizations, and prospective employers in the US, can train and support newcomers to regulatory affairs. These entry-level individuals include those making a midcareer transition from another field to regulatory affairs and who have work experience but not in the regulatory setting and recent undergraduates or graduates with master's degrees in regulatory affairs but with no work experience. The article also addresses the shortage of qualified and experienced regulatory affairs professionals, the challenges for both job candidates and employers in filling positions, and how these contribute to the prevailing talent gap in the profession. The article is based on a presentation at the Regulatory Affairs Professionals Society (RAPS) Annual Convergence in Montreal, Canada, in October 2023.1

Welcome to the December issue of RF Quarterly, featuring selected presentations from the 2023 RAPS Convergence and including articles on pediatric drug development, the FDA's proposed ACNU rule, clinical evidence from a notary body perspective, submission content considerations for combination products, and attributes for successful regulatory leadership.

This article examines seven aspects of leadership that, if developed intentionally and practiced regularly, can help regulatory leaders at all levels succeed as people leaders and business partners.

Ten RAPS members share their experiences and advice on how to build, strengthen, and develop a rewarding career in regulatory through active engagement in RAPS. Collectively, they have more than 212 years of professional experience. Among them there are four RAPS award recipients, five current chapter leaders, three past RAPS chapter chairs, and three professionals who are just starting their regulatory journey but have already made a positive impact on the RAPS community. By sharing their stories, they hope to inspire readers to reach higher, achieve more, and trailblaze a path on their respective unique leadership journeys.

Strong leadership skills are the foundation for professional success. Demonstrating effective leadership as a regulatory professional requires mastering a range of diverse but interconnected competencies. This article uses the six elements of the leadership domain as defined by the RAPS Regulatory Competency Framework1,2 – collaboration, communication, conflict management, negotiation, talent management, and relationship management – as the starting point for discussing the key leadership skills that are essential for regulatory professionals.

Welcome to the September issue of RF Quarterly, which focuses on leadership in regulatory affairs. The issue includes articles on the leadership experience, leading without formal authority, essential regulatory leadership skills, and the regulatory leadership roles in small biotech companies.

As leaders in the regulatory field there are several key qualities that every professional should develop in their career. However, in small biotech, which is often characterized as fast-paced, consistently evaluating financing opportunities, and building company structure and culture as the company grows, there are some key qualities that are foundational to being a successful regulatory leader in this environment. These foundational characteristics are trusted collaboration, clear communication, developing a growth mindset and building resilience. This foundation provides a regulatory leader in small biotech with the tools needed for contributing to successful development programs and building a strong relationship with regulatory bodies.

Regulatory affairs professionals continually seek opportunities to grow and gain new abilities in their areas of interest. One of those areas is leadership; however, not all leaders have the capability to formally lead a team or group. These astute professionals have the opportunity to learn how to lead without formal authority. In this article, the authors discuss key qualities of a leader and the specific approaches to developing a leadership skillset without formal authority.

The global regulatory profession is facing a shift in the definition of leadership success. This article aims to shed some light on important aspects of leadership. In the context of the article, leadership is defined as the power of making a difference. It explains why critical thinking, business acumen, emotional intelligence, team building, influence, and mentorship play a vital role in building leaders and why regulatory professionals should use these tools to become successful leaders.

The Regulatory Affairs Certification (RAC) is a professional certification from the Regulatory Affairs Professionals Society (RAPS) to demonstrate an individual's ability to navigate the complex landscapes in the pharmaceutical, biotechnology, and medical device industries. Candidates must pass a rigorous examination that tests their knowledge of regulations governing the development, approval, and marketing of products. This article offers tips to successfully navigate the RAC journey from deciding to take the exam to beyond the test day. Keywords – examination tips, professional development, RAC, certification