Knight aspires to be the leading Pan-American (ex-US) partner of choice, with a growing portfolio of innovative and high-quality branded products. The General Clinical Regulatory Associate will enable this corporate ambition, by contributing directly or indirectly to its strategic priorities: in-licensing and developing new products across Pan-American
markets (ex-US), achieving aggressive top line growth for promoted products and maximizing bottom line contribution across portfolio, and being an organization that acquires, develops, and retains critical talent. The Global Clinical Regulatory Associate at Knight Therapeutics advises on clinical regulatory strategy by evaluating, interpreting, and integrating clinical information and study results provided by licensing partners, together with relevant published literature and other external evidence. The role supports regulatory submissions and lifecycle activities and coordinates with cross-functional colleagues (QA, Regulatory Affairs, Medical Affairs, and Commercial) and external partners to develop, assess, and maintain project timelines.



This role does not involve sponsoring, designing, or conducting clinical studies on behalf of Knight.

Role Responsabilities:
● Support the preparation of pre-submission clinical regulatory packages.
● Work collaboratively with medical, regulatory, and commercial to support alignment on clinical regulatory strategy.
● Coordinate with vendors (medical writing, statistician, clinical pharmacology) for document preparation wherever applicable, tracking deliverables and timelines against agreed schedules.
● Contribute to clinical regulatory strategy by preparing evidence summaries, gap analyses, and background research based on clinical information and study documentation provided by licensing partners, supplemented by relevant published literature and other external sources.
● Develop and maintain working subject-matter knowledge of assigned products and therapeutic areas; respond t

📌 Global Clinical Regulatory Associate (Bogotá)
🏢 Knight Therapeutics Colombia
📍 Bogotá