Senior Specialist, US Regulatory Affairs Operations

Our client is a global, research-driven pharmaceutical focusing on treatment options for diseases and conditions for which there is no satisfactory treatment option to date. The company is looking for a Regulatory Affairs Specialist to join the team. This is an amazing opportunity to work on cutting edge treatments and make a difference!This is a HYBRID role in St. Joseph, MO (Onsite 2-3 days a week)Schedule: M-F Hours between 8am -5pmType of Job: 18 month ContractPay: $30-36/hourResponsibilities:• Prepare high quality US regulatory submissions required by local and federal agencies to maintain BI products on the market.• Supervision prepares regulatory submissions for activities such as labeling supplements, DERs, EPA monthly and aggregate reports, drug product listing, establishment registration, advertising and promotional materials, product import, pesticide state adverse event reporting, state licensing renewals, state product renewals, and tonnage reporting.• Contribute to the development and implementation of processes and work instructions.• Understand and monitor regulatory trends; understand and implement regulations and guidance. Interact with the authorities in a professional manner.• Responsive to government agencies for questions on submissions.• Support systems for product compliance and maintenance.• Ensures company interests are supported/maintained in negotiations with regulatory authorities resulting from requests and information received from regulatory authorities.Qualifications:• Bachelor's degree and 1-year relevant industry experience OR associate’s degree and 3 years relevant industry experience.• Preferred experience in lieu of a degree, 5 years relevant industry experience including 1 year of related regulatory experience.#INDBH