Easter Seals Jobs

Serve as a subject matter expert and mentor for staff and as a technical interface for clients. Transform the client’s business by developing and implementing regulatory plans to ensure the lead delivery of regulatory and quality solutions providing best practice and innovative solutions. Lead in the drafting of complex worldwide regulatory strategies and worldwide regulatory submissions. Prepare and monitor regulatory compliance reports. Create the development of complex Master Validation Plans using risk based approaches. Lead subsequent process validation activities. Lead quality system development & improvement programs, quality audits, design assurance activities (design verification/validation), FDA mock audits, and supplier audits. Lead regulatory strategies and implementation plans for the preparation and submission of new products and provide regulatory guidance to teams.Special Requirements:Experience in: regulatory submission; compliance (cGMP, GDP, GDocP, GCP); labeling & packaging records; process validation & sampling protocol; DSCSA & Serialization Optel; and working with: eCTD & SPL.Relocation and travel to various unanticipated locations within USA possible. Employer will accept suitable combination of education, training or experience.