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Senior Director, Global Regulatory Lead, Rare Diseases at LEO Pharma in Madison, NJ



$200K — $250K *


Life Sciences


11 - 15 years

Job Description

What a Senior Global Regulatory Lead on our Global Regulatory Department at LEO Pharma will fulfill:

As the Senior Global Regulatory Lead, you will be responsible to lead the global, US, and EU regulatory strategy and for assigned programs in the innovative portfolio working in partnership with the Global Program Teams, other functions in R&D, commercial, and Global Product Supply. Key focus is on new MOAs, drug delivery systems, drug-device combinations, biologics and in the rare disease space.

Your contribution to the team would include:

  • Represent Global Regulatory Affairs (GRA) in the program team(s) and drive the regulatory strategy with cross-functional teams.
  • Overall accountable for creating and driving global regulatory strategies and deliverables for development and life cycle management including maintenance activities for assigned program(s).
  • Responsible for the g
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Valid through: 7/16/2020

About LEO Pharma

Leo Pharma A/S is a multinational Danish pharmaceutical company, founded in 1908, with a presence in about 100 countries. Its headquarters are in Ballerup, near Copenhagen The company is 100% integrated into a private foundation owned by the LEO Foundation. Leo Pharma develops and markets products for dermatology, bone remodeling thrombosis and coagulation. In 1945 it was the first producer of penicillin outside the USA and UK. In 1908, pharmacists August Kongsted and Anton Antons bought the LEO Pharmacy in Copenhagen, Denmark. With the purchase, they established 'Københavns Løveapoteks kemiske Fabrik', today known as LEO Pharma. LEO Pharma celebrated its centennial in 2008. Flags bearing the LEO logo were flying in every country where LEO products are available, more than a hundred flags in total. Today, LEO Pharma has an ever growing pipeline with over 4,800 specialists focussing on dermatology and thrombosis. In 2015, the company announced it would acquire Astellas Pharmas dermatology business for $725 million.
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