Director, US Regulatory Strategy - Military veterans preferred

Meet's partenered with a global pharmaceutical manufacturing company on an exciting new search for a Director, US Regulatory Strategy! You'll be responsible for creating and implementing regulatory strategies, directing and implementing the preparation of US Regulatory submissions, meeting deadlines for regulatory agencies, shortening the review process, and receiving successful approval of pharmaceutical applications. Responsibilities : Develop and implement US regulatory strategy. Act as the primary point of contact with the FDA and plan and lead meetings. Lead and prepare FDA submissions. Participate in glab project team meetings to provide regulatory support and guidance. May act as the single regulatory representative. Review and interpret regulatory guidelines. Qualifications : Bachelor's degree required. Masters, PharmD, PhD, MD, or JD preferred 10+ years in the pharmaceutical industry required. 8+ years in regulatory affairs. Experience providing regulatory strategy for the drug development process. Interpret and understand US regulations governing the pharmaceutical industry. Ability to travel up to 30% If you're interested in hearing more about this opportunity please apply or send your resume to carlos@peoplewithchemistry.com

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