Regulatory Affairs Specialist

Yoh is hiring a Regulatory Affairs Specialist for our Pharmaceutical Manufacturing client in St. Louis, Missouri. Essential Job Functions Authoring, organization, and preparation of electronic (eCTD) regulatory filings; also includes peer review of filings. Understand, identify potential regulatory risks and recommend strategies based on current FDA/health authority requirements. Manage multiple priorities. Attend necessary trainings and seminars to keep abreast of new and/or changes in the Regulatory profession. Process, interpret and provide recommendations for complex, unusual issues. Critically review documentation for regulatory submissions and provide input for necessary revisions. Must maintain operational compliance with US and international regulatory agencies and guidelines (i.e. FDA, EU, HC, TGA, PIC/S, ISO, USP, NRC, cGMP, etc.). Education and Experience Requirements Bachelor Degree in scientific discipline required or equivalent work experience. 5 or more years of Regulatory experience or related field. RAC certification preferred. Cross functional interaction experience, coordinating activities, driving projects and initiatives to completion, and working to align communications with other departments is required. Project leadership or supervisory experience is required. Estimated Min Rate: $37.00 Estimated Max Rate: $47.00 What’s In It for You? Medical, Prescription, Dental & Vision Benefits (for employees working 20+ hours per week) Health Savings Account (HSA) (for employees working 20+ hours per week) Life & Disability Insurance (for employees working 20+ hours per week) MetLife Voluntary Benefits Employee Assistance Program (EAP) 401K Retirement Savings Plan Direct Deposit & weekly ePayroll Referral Bonus Programs Certification and training opportunities Note: Any pay ranges displayed are estimations. Actual pay is determined by an applicant's experience, technical expertise, and other qualifications as listed in the job description. All qualified applicants are welcome to apply. Yoh, a Day & Zimmermann company, is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran. If you have a disability and require accommodation in the application process, please contact us at By applying and submitting your resume, you authorize Yoh to review and reformat your resume to meet Yoh’s hiring clients’ preferences. To learn more about Yoh’s privacy practices, please see our Candidate Privacy Notice: #J-18808-Ljbffr