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Specialist, US Regulatory Affairs Operations

Saint Joseph, MO 64506

Posted: 07/10/2024 Employment Type: Contract Job Category: Regulatory Sciences and Medical Writing Job Number: 608147 Is job remote?: No Country: United States

Job Description


Job Description:
  • With minimum guidance, prepare high quality US regulatory submissions required by local and federal agencies to maintain products on the market.
  • With minimum guidance and supervision prepare 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.
  • With minimum guidance and supervision, 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.
  • With minimum guidance and supervision, support systems for product compliance and maintenance.


Skills:    
  • *Note strong requirement for proficiency in MS Office applications and Adobe Acrobat
  • General knowledge in relevant Regulatory Affairs areas. General knowledge and understanding of regulatory legislation and requirements for the maintenance of veterinary products
  • General knowledge of the legal requirements for maintenance of veterinary medicinal products.
  • Maintains compliance with respect to all requirements for assigned products. 
  • Ensures company interests are supported/maintained in negotiations with regulatory authorities resulting from requests and information received from regulatory authorities.
  • Proficient in standard office technology, including Word, Excel, and Adobe Acrobat.
    • Strong written and verbal communication skills
    • Strong attention to detail
    • Must exhibit good judgment, and ability to problem-solve issues in daily work
    • Demonstrated ability to successfully collaborate in a global organization and manage a full workload.
    • Able to meet stringent time and quality demands.
    • Self-motivated with a high degree of initiative, commitment and persistence.
    • Well developed organizational capabilities.
    • Strong team player who is collaborative with the mission of BI, but able to drive change.
    • AI Competencies
  • Accountability: Taking ownership for decisions and actions.
  • Agility: Quickly acting with an open mind to face internal and external circumstances. Intrapreneurship: Together with our customers, internal or external, creating innovative ideas to respond to changing needs.

Education:    
  • Bachelor's degree and 1 year relevant industry experience 
OR
  • Associate’s degree and 3 years relevant industry experience
OR
  • In lieu of a degree, 5 years relevant industry experience including 1 year of related regulatory experience





Pay Rate Range: $40-57/hr. Salary will be commensurate with experience

The staffing industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly and never provide banking information during the application process. Candidate safety is a top priority at Planet Pharma.

Planet Pharma is an equal opportunity employer. It is our practice not to discriminate against any employee or applicant based on any criteria, condition or basis protected by laws or regulations in the locations where we do business. All qualified applicants are encouraged to apply. We celebrate diversity and are committed to providing an environment of mutual respect. We believe that diversity, equity and inclusion enable us to better meet our mission and values while serving our clients across the globe. If you have a disability or handicap and would like us to accommodate you in any reasonable way, please inform your recruiter, or contact us, so that we can discuss the appropriate alternatives available.

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About Saint Joseph, MO

Discover exciting job opportunities in the bustling area around Saint Joseph, Missouri! Nestled along the Missouri River, this vibrant region offers a perfect blend of small-town charm and big-city amenities. With a thriving economy, diverse industries, and a welcoming community, Saint Joseph provides endless growth prospects for job seekers. Explore positions in healthcare, education, manufacturing, and more in a region known for its rich history, including landmarks like the Pony Express Museum and the Jesse James Home. Indulge in local delicacies like the famous Kansas City-style BBQ or catch a show at the historic Missouri Theatre. With scenic parks, such as Krug Park, and a variety of recreational activities, Saint Joseph is a hidden gem just waiting for you to make your mark. Start your career journey here today!

Although this hasn't been an issue at Planet Pharma, the staffing industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly and never provide banking information during the application process. Candidate safety is a top priority at Planet Pharma.