Profile

Ms. Kimberly Belsky

Mallinckrodt Pharmaceuticals

Contact Details

Mallinckrodt Pharmaceuticals

Bio

An energetic regulatory professional with broad pharmaceutical experience. Demonstrated leadership in US labeling and Adpromo functions (Rx, OTC, dietary supplement, cosmetic, device) as well as development and implementation of processes to enhance efficiency and compliance.

As a regulatory policy and intelligence professional, analyzes and communicates emerging global regulatory requirements (including US Congressional activities), trends, and approvals to support the development of regulatory strategies and shape policies that impact the global pharmaceutical business (Rx Brand, Generics, OTC, Dietary Supplements, and Devices). Passionate about shaping the regulatory environment through the development of company position and the commenting process. Excels at distilling/communicating information and achieving consensus on complex issues.

Broad management experience including oversight of regulatory activities for the global expansion of marketed pharmaceutical products into other countries and regions. Strengths include public speaking/presentations (e.g., internal, DIA, RAPS, industry trade group conferences).