Title : US Regulatory Affairs Operations Specialist
Location : St. Joseph, MO or Athens, GA
Duration : Months
Pay rate : $ on W
Part time role - hours per week and requirement to be in the office - days a week
Anywhere between : am to : pm, Monday-Friday as scheduled.
Duties :
- 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 :
- 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 client, 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 year relevant industry experience OR Associate's degree and years relevant industry experience OR In lieu of a degree, years relevant industry experience including year of related regulatory experience.
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