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Subject: Senior Principal Specialist in St. Joseph, MO - send resumes to dan.wienczkowski@rightthinginc.com

Dan Wienczkowski, ACIR, CIR, CDR, CSSR, PRC posted a job: Senior Principal Specialist in St. Joseph, MO - send resumes to dan.wienczkowski@rightthinginc.com

"Title: Senior/Principal Specialist Location: St. Joseph, MO Responsibilities: - Review/ prepare scientific/technical information related to regulatory submissions or regulatory compliance. Prepare/file/review regulatory submissions which may include safety, efficacy, CMC, labeling to FDA-CVM. - Provide guidance/direction/training within the regulatory department and to other departments relative to regulatory compliance, submission requirements, time lines or FDA-CVM expectations. - Provide guidance and consultation on product development, including active project team participation as US RA core team member. - Act as liaison to FDA/DVM and regulatory groups, as requested. Understand/monitor regulatory trends and work with SAD to inform organization of new guidelines, directives, and agency initiatives. - Participate in drafting and review of departmental processes and SOPs for activities relevant to this position and performs special projects as assigned. - Provide regulatory project guidance to team members, Specialists and/or Senior Specialists as required. - In his/her absence, as requested, assume responsibilities of Senior Associate Director, Reg Affairs. - Align with global regulatory objectives and execute as per plan. Requirements: - Doctoral degree (e.g. PhD, MD, DVM) or Master's degree in Biology or Chemistry. - Veterinarian with 1-2 years direct pre-approval pharmaceutical regulatory experience or a Master's of Science with a minimum of 8 years of experience in pre-approval pharmaceutical regulatory affairs or in pharmaceutical clinical development. - Direct knowledge of regulatory requirements for demonstration of safety & effectiveness including principals of study conduct, statistics and design. Eligibility Requirements: - Must be legally authorized to work in the United States without restriction. - Must be willing to submit to a background investigation, including verification of your past employment, criminal history, and educational background - Must be willing to take a drug test and post-offer physical (if required) - Must be 18 years of age or older Desired Experience, Skills and Abilities: - Multidisciplinary problem solving, time management and regulatory strategy skills. - High degree of detail orientation and excellent verbal and written communication skills. - Professional customer focused approach. Please email your resume to - dan.wienczkowski@rightthinginc.com"

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