Senior Director, Global Regulatory Affairs Strategy

Job Overview:

The Senior Director of Global Regulatory Affairs Strategy (GRAS) will work closely with sponsor companies in developing regulatory strategies that will support drug development initiatives. This responsibility will include leading client interactions with Regulatory Agencies globally. This position will also work as an internal consultant/advisor across various Covance business units to facilitate dialogues with our clients to develop relevant regulatory strategy and tactical plans to meet their drug development needs globally.

The Senior Director of Global Regulatory Affairs Strategy can be an office-based or home-based role located anywhere within the United States. Education/Qualifications:

An advanced degree with a focus in the sciences is required, an MD or PhD is preferred. Experience:

Minimum Required:   The ideal candidate will possess 15 + years experience of drug development in the Pharma, biotech or CRO industry with at least 9 years experience in regulatory affairs developing global regulatory strategies for early and late stage development programs.  

 Experience in discovery research, preclinical pharmacology, toxicology, or clinical research required. Experience in cell and gene therapy desired. Proven history of finding novel solutions to challenging drug development issues and developing innovative regulatory strategies. Knowledge of regulatory guidance in multiple regions and industry best practices for drug development Experience with leading strategic planning, preparation and execution of Agency interactions. Experience leading teams through IND, CTA development, addressing agency questions to support the start up of clinical trials Experienced in leading teams through NDA/MAA development, submission and addressing Agency inquiries. Leadership role in HA negotiations in multiple regions/countries. The ability to develop effective multi-cultural relationships. Global people management/leadership experience required Excellent organizational skills and the ability to manage multiple important projects with tight timelines is essential.

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